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Specifications as amended, taking into account amendments up to Medicines Advisory Statements Amendment Specification 2015 (No.1)
Administered by: Health
Registered 13 Jul 2015
Start Date 19 May 2015
Date of repeal 01 Jul 2017
Repealed by Medicines Advisory Statements Specification 2017
Table of contents.

Commonwealth Coat of Arms

Medicines Advisory Statements Specification 2014

as amended

made under subsection 3(5A) of the

Therapeutic Goods Act 1989

Compilation start date:                     19 May 2015

Includes amendments up to:            Medicines Advisory Statements Amendment Specification 2015 (No.1)

 

 

 

 

 

 

 

 

 

 

Prepared by the Therapeutic Goods Administration, Department of Health

 

About this compilation

This compilation

This is a compilation of the Medicines Advisory Statements Specification 2014 as in force on 19 May 2015. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 9 July 2015.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

 

 

  

  

  


Contents

Introduction   4

1                 Name of Specification   5

2                 Commencement 5

3                 Transitional Arrangements  5

4                 Definitions  5

5                 Medicines Advisory Statements  8

Schedule 1  9

Required Advisory Statements for Medicine Labels No. 1  10

Advisory statements  10

Permitted variation and combination of advisory statements  10

Additional presentation requirements for some advisory statements  10

Table 1: Medicines to which advisory statements apply  11

Schedule 2  56

Required Advisory Statements for Medicine Labels No. 2  57

Advisory statements  57

Permitted variation and combination of statements  57

Additional presentation requirements for some advisory statements  57

Table 1: Medicines to which advisory statements apply  59

Endnotes  146

Endnote 1—About the endnotes  146

Endnote 3—Legislation history  149

Endnote 4—Amendment history  150

Endnote 5—Uncommenced amendments [none] 151

Endnote 6—Modifications [none] 151

Endnote 7—Misdescribed amendments [none] 151

Endnote 8—Miscellaneous [none] 151

 


 

Introduction

This Specification sets out advisory statements that are required to be included on the labels of medicines to which the Specification applies, if they contain particular ingredients (in most cases, this relates to active ingredients only).

 

The advisory statements set out in the Specification are designed to address specific risks related to the use of medicines that have been identified via pharmacovigilance activities, testing, adverse event reports or other scientific or clinical information.

 

Having advisory statements on medicine labels therefore ensures that consumers are informed about these risks.

 

It is important to note that medicines that are mentioned in Part 1 of Schedule 10 to the Regulations – which are comprised of prescription medicines and medicines such as medical gasses, radiopharmaceuticals and dialysis solutions – are not required to comply with the Specification.

 

The exclusion of these products reflects that access to prescription medicines is controlled by registered medical practitioners, and that information about the potential benefits and risks of a medicine is part of the consultation between patient and prescriber rather than needing to be included on a medicine’s label.  Also, the risk-benefit profile of such medicines may vary considerably from patient to patient.

 

In relation to radiopharmaceuticals and the like, in most cases these are not supplied directly to consumers but are utilised in a treatment setting such as a hospital.

 

In addition to the above, medicines that are not mentioned in Part 1 of Schedule 10 to the Regulations but for which the Secretary or her delegate has consented to their import, supply or export notwithstanding that they do not comply with a requirement to include an advisory statement on their label (and which comply with the terms of that consent), will also not be required to comply with the Specification.

 


 

1   Name of Specification

This Specification is the Medicines Advisory Statements Specification 2014.

2   Commencement

This Specification commences on the day after it is registered on the Federal Register of Legislative instruments.

3   Transitional Arrangements

(1)  From the date of commencement of this Specification until the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 1 to this Specification.

Note 1:    Nothing in (1) is intended to prevent a person from complying with the requirements in Schedule 2 in relation to a medicine in a prescribed class between the date of commencement of this Specification and the day 18 months after the date of that commencement, if they wish to do so.

(2)  From the day 18 months after the date of commencement of this Specification, medicines in a prescribed class must comply with the requirements specified in Schedule 2 to this Specification.

4   Definitions

(1)  In this Specification:

Act means the Therapeutic Goods Act 1989

dermal use means application to the skin primarily for localised effect

divided preparation means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules

dosage unit means an individual dose of a medicine for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules

essential oils means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation.  It also means:

(a)       oils of equivalent composition derived through synthetic means; or

(b)      compounded oils of equivalent composition comprising a mixture of synthetic and natural components

external in relation to the use of a medicine means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice

internal use means administration:

(a)       orally, except for topical effect in the mouth; or

(b)      for absorption and the production of a systemic effect,

             (i)           by way of a body orifice other than the mouth; or

             (ii)         parenterally, other than by application to unbroken skin

Labelling Order means the order in force made under section 10 of the Act and published on the Federal Register of Legislative Instruments, specifying general requirements for labelling of medicines

listed medicine means a medicine that is listed in the Register under sections 26 or 26A of the Act

main label means:

(a)         where there are two or more labels or two or more portions of a single label – that label or portion of the label where the product name is more or most conspicuously shown; or

(b)         where the product name is equally conspicuous on two or more labels or portions of a label –each such label or portion.

medicine has the same meaning as in the Act

medicine in a prescribed class means medicine in a class prescribed in regulations for the purposes of paragraph 3(5)(ca) of the Act – these medicines are defined in regulation 3AA of the Regulations as:

medicine for supply in Australia that is not:

(a) a product of a kind mentioned in Part 1 of Schedule 10; or

(b) a medicine that satisfies the following requirements:

(i)       the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;

(ii)      the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);

(iii)    the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii)

MRDD (Maximum recommended daily dose) is the maximum approved dose per day for a medicine used for its main indication in adults

Regulations means the Therapeutic Goods Regulations 1990

signal heading means the signal word or words relating to the Schedule of the SUSMP in which the substance is included and the purpose for which it is to be used, as shown in the following table:

 

 

Schedule

Purpose

Signal Words Required

2

For any purpose

PHARMACY MEDICINE

3

For any purpose

PHARMACIST ONLY MEDICINE

4

For human use

PRESCRIPTION ONLY MEDICINE

5

For any purpose

CAUTION

6

For any purpose

POISON

7

For any purpose

DANGEROUS POISON

8

For any purpose

CONTROLLED DRUG

 

SUSMP means the Standard for the Uniform Scheduling of Medicines and Poisons, as set out in Schedule 1 of the current Poisons Standard

topical use means application of a substance for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied

(2)         Unless the contrary intention appears, a reference to a substance in this Specification includes:

                a.             that substance prepared from natural sources or artificially; and

b.            where the substance is a plant (other than a plant referred to in Schedules 8 or 9 of the SUSMP), that plant or any part of that plant when packed or prepared for therapeutic use; and

c.             every salt, active principle or derivative of the substance, including esters and ethers and every salt of such an active principle or derivative; and

d.            every alkaloid of the substance and every salt of such an alkaloid; and

e.             except where the stereoisomer is defined in the substance name (e.g. dextromethorphan), every stereoisomer of the substance and every salt of such a stereoisomer; and

f.             a preparation or admixture containing any proportion of the substance,

                but does not include:

                g.             a preparation or product included in Appendix A of the SUSMP; or

h.            a substance included in Appendix G of the SUSMP at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of the substance; or

i.              any other substance included in Schedules 1 to 6 of the SUSMP, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8 of the SUSMP.

(3)         Unless the contrary intention appears, where a  concentration, strength or quantity is specified in this Specification in respect of a substance:

a.             if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in this Specification; and

b.            the expression “one per cent” means:

i.              in the case of a liquid preparation, 1 gram of the substance per 100 mL of the preparation; or

ii.            in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation and

iii.           any expression of greater or lesser percentages shall have a corresponding meaning; and

c.             in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.

 

5   Medicines Advisory Statements

The advisory statements mentioned in Schedule 1 and Schedule 2 are specified under subsection 3 (5A) of the Act for the purposes of paragraph 3(5)(ca) of the Act.

 

 

 

 

 


 

.

 

Schedule 1

 

 

 

Required Advisory Statements for Medicine Labels No. 1

 

(section 5)


 

Schedule 1    

Required Advisory Statements for Medicine Labels No. 1

Advisory statements

Where a medicine:

1)     includes a substance described in Column 1 of Table 1:Medicines to Which Advisory Statements Apply (‘the table’), below; and

2)     meets the condition(s) described in Column 2 of Table 1;

 

the statement(s) set out in Column 3 of the table must be contained on the labels of the medicine in accordance with the Labelling Order, in a manner that is compliant with any applicable presentation requirement(s) set out below (the requirements are indicated in the table by the presence of the applicable alphabetical in square brackets, next to the statement or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself).

Unless otherwise specified, the requirements apply only if the substance is included in the medicine as an active ingredient.

Permitted variation and combination of advisory statements

The wording of the statements specified in Column 3 of Table 1 of this Schedule may be varied provided that the intent is not changed.

Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent is not changed and that any presentation requirements (see below) are also met.

Additional presentation requirements for some advisory statements

In some cases, additional requirements apply to advisory statements, such as font, letter size etc.   Where such additional requirements apply, they are indicated in Column 3 of Table 1 below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of  upper case and/or bold face letters in the statement itself.   The meaning of the letters is set out below:

 [c]: Statement(s) must be included in the directions for use on the label.

 [f]:  Statement(s) must be included on the label written:

(i)    on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and

(ii)   in bold-face sanserif capital letters of uniform thickness; and

(iii)  in letters as least four tenths the height of the letters used for the signal heading; and

(iv) with nothing else besides the statement written on the same line.

[g]: Statement(s), written in sanserif capital letters, must be included on the main label or as part of the directions for use.

[k]: Statement(s) must be printed in type of 3 mm height or larger.

[l]: Statement(s) must be printed on the front of the goods.

Note: Meaning of notes in Column 1 of the table

To assist sponsors to prepare for compliance with amended requirements in Schedule 2 to the Medicines Advisory Statement Specification 2014, the following Note is included in Column 1 of the table, where applicable: ‘NB: entry amended in Schedule 2’.

Table 1: Medicines to which advisory statements apply

 

Column 1

Substance(s)

 Column 2

Conditions

Column 3

Required statement(s)

Acetone

In concentrations greater than 75 per cent

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes 

Avoid contact with skin

Avoid breathing [vapour/spray mist].

·   DO NOT SWALLOW.[g]

Actaea racemosa

 

(previous name Cimicifuga racemosa)

 

In listed medicines

·     Warning: In very rare cases, Black cohosh has been associated with liver failure.

·     If you are experiencing yellowing of the skin or whites of the eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see your doctor.

Activated charcoal

In listed medicines

·   Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.

 

·     This substance may interact with other medicines.

·     Activated charcoal is not recommended for long term use.

Ademetionine

In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts

·     Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.

(S)-S-Adenosylmethionine

In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts

·     Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.

Alclometasone

When included in Schedule 3 to the SUSMP

 

·     CAUTION - do not use for children under 2 years old unless a doctor has told you to.

·     Do not use in the eyes.

·     Do not use for acne.

·     Do not use under waterproof bandages unless a doctor has told you to.

·     Do not use for more than 7 days unless a doctor has told you to.

Anise oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of anise oil; and

b.       packed in containers having a nominal capacity of 50 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Antihistamines 

NB: entry amended in Schedule 2

When included in a schedule to the SUSMP and NOT separately specified in the table and NOT:

a.        dermal, ocular or  paediatric preparations; or

b.       oral preparations of desloratadine, loratadine or fexofenadine; or

c.        nasal preparations of azelastine

either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.

or

·         This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

 

Arginine

In listed medicines

·     This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa, vagina or rectum.

Aspirin

(Entry 1 of 7)

NB: entry amended in Schedule 2

For the purpose of exclusion from the schedules to the SUSMP when:

a.        each dosage unit contains MORE than 100 milligrams of aspirin; and

b.       the preparation is NOT indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing aspirin or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·     See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 2 of 7)

NB: entry amended in Schedule 2

For the purpose of exclusion from the schedules to the SUSMP when:

a.        each dosage unit contains MORE than 100 milligrams of aspirin; and

b.       the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing aspirin or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

Aspirin

(Entry 3 of 7)

NB: entry amended in Schedule 2

For the purpose of exclusion from the schedules to the SUSMP, when:

a.        each dosage unit contains 100 milligrams or LESS of aspirin, and:

b.       the preparation IS indicated for the prevention of cardiovascular disease or for inhibition of platelet aggregation

·     For use under medical supervision only.

Aspirin

(Entry 4 of 7)

NB: entry amended in Schedule 2

When included in a schedule to the SUSMP and:

a.        the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

b.       in sustained release preparations containing 650 milligrams or more of aspirin

·     For use under medical supervision only.

Aspirin

(Entry 5 of 7)

NB: entry amended in Schedule 2

 

When included in a schedule to the SUSMP, and:

a.        the preparation IS indicated exclusively for treatment of dysmenorrhoea; and

b.       NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.        NOT in combination with other therapeutically active substances (other than effervescent agents)

 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing aspirin or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·     See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 6 of 7)

NB: entry amended in Schedule 2

 

When included in a schedule  to the SUSMP, and:

a.        in combination with other therapeutically active substances (other than effervescent agents); and

b.       NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.        the preparation is NOT indicated:

i.   for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

ii. exclusively for treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing aspirin or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

Aspirin

(Entry 7 of 7)

NB: entry amended in Schedule 2

 

When included in a schedule to the SUSMP and:

a.        NOT in combination with other therapeutically active substances (other than effervescent agents); and

b.       NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.        the preparation is NOT indicated:

i.   for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

ii. exclusively for treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing aspirin or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·     See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Azadirachta indica (Neem)

(Entry 1 of 2)

When:

a.        in listed medicines containing more than 1% of cold pressed neem seed oil; or

b.       for the purpose of exclusion from the schedules to the SUSMP when in preparations for dermal use and in a container fitted with a child resistant closure

·     Not to be taken.

·     Keep out of reach of children.

·     Do not use if pregnant or likely to become pregnant.

 

Azadirachta indica including its extracts and derivatives

(Entry 2 of 2)

When included in Schedule 6 to the SUSMP

·     Do not use if pregnant or likely to become pregnant.

Backhousia citriodora

In listed medicines

·     Not recommended for use by children aged 12 years or under.

·     Not recommended for use by pregnant or lactating women.

·     If skin irritation occurs, discontinue use.

Basil oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations or oils containing more than 5 per cent of methyl chavicol; and

b.       packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Bay oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.  in preparations containing more than 25 per cent of bay oil; and

b. packed in containers having:

        i.          a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.         a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

 

Benzoyl peroxide

When included in Schedule 2 to the SUSMP

 

·   Keep from eyes, lips, mouth and sensitive areas of the neck.

·   If excessive swelling, irritation, redness or peeling occurs, discontinue use.

·   If these persist, consult a physician.

·     Avoid excessive exposure to sunlight and other sources of ultra violet light.

Bergamot oil

 

For the purpose of exclusion from the schedules to the SUSMP; or when included in a schedule to the SUSMP 

·     Application to skin may increase sensitivity to sunlight.

Bovine colostrum powder

In listed medicines

·     Products containing bovine colostrum powder contain lactose and cow’s milk proteins.

·     This product is not suitable for use in children under the age of 12 months except on professional health advice.

Bovine lactoferrin

In listed medicines

·     Derived from cow’s milk.

Caffeine

(Entry 1 of 2)

In listed medicines, except medicines containing less than 1 milligram of caffeine in the MRDD:

a.        for oral or sublingual administration; and

b.       the MRDD of which contains 10 milligrams OR LESS of caffeine or less; and

c.        when the caffeine is from a herbal source

·     The recommended dose of this medicine provides small amounts of caffeine.

Caffeine

(Entry 2 of 2)

 

In listed medicines:

a.        for oral or sublingual administration; and

b.       the MRDD of which contains MORE THAN 10 milligrams of caffeine; and

c.        when the caffeine is from a herbal source

·     Contains [amount of caffeine in milligrams] mg of caffeine.

Cajuput oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations or oils containing more than 25 per cent of cajuput oil; and

b.       packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Calcium sodium caseinate

In listed medicines

Either

·     Derived from cow’s milk.

or

·     Contains cow’s milk protein.

Camphor

(Entry 1 of 3)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.  included as a natural component in essential oils containing more than 2.5 per cent of camphor but 10 per cent or less of camphor; and

b. packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Camphor

(Entry 2 of 3)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.  in essential oils when the camphor is present as a natural component of the oil; and

b. packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Camphor

(Entry 3 of 3)

When:

     i.        included in a schedule to the SUSMP, and

    ii.       not in block, ball or pellet form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents.

·     Either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·     SAFETY DIRECTIONS

Can be fatal to children if sucked or swallowed.

Avoid contact with eyes.

 

Canarium indicum 

In listed medicines

·     This product contains material derived from nuts.

Cassia oil

When included in a Schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with skin.

·   DO NOT SWALLOW. [g]

Charcoal – activated

In listed medicines

·     Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.

·     This substance may interact with other medicines.

·     Activated charcoal is not recommended for long term use.

Chelidonium majus

When the preparation is for oral use

·     Warning: Greater Celandine may harm the liver in some people.

·     Use only under the supervision of a healthcare professional.

Chromates (including dichromates) of alkali metals or ammonia

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes

Avoid contact with skin

Avoid breathing [dust]/[vapour]/[ spray mist].

Cimetidine

When included in Schedule 3 to the SUSMP

·     Use only under medical supervision if you are taking other medicines.

·     CAUTION: This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.

·     If symptoms persist or recur within two weeks of completing the course, consult a doctor.

Cineole

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations or oils containing more than 25 per cent of cineole (other than rosemary oil or camphor oil); and

b.       packed in containers having:

     i.        a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

    ii.       a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

 

Cinnamon bark oil

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with skin.

·   DO NOT SWALLOW. [g]

 

Cinnamon leaf oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 25 per cent of cinnamon leaf oil; and

b.       packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

 

Clobetasone

In Schedule 3 to the SUSMP

·         Do not use in the eyes.

·         Do not use for acne.

·         Do not use under waterproof bandages unless a doctor has told you to.

·         Do not use for more than 7 days unless a doctor has told you to.

·         CAUTION - Do not use for children under 12 years old unless a doctor has told you to.

Clotrimazole

In preparations for vaginal use   

·     Seek medical advice before first course of treatment.

·     See a doctor if you are pregnant or diabetic.

·     See a doctor if no better after [Insert number of days as per approved Product Information] days.

·     See a doctor if problem returns.

Clove oil

(Entry 1 of 2)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 25 per cent of clove oil; and

b.       packed in containers having:

     i.        a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

    ii.       a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Clove oil

(Entry 2 of 2)

 

When included in a Schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes.

·     DO NOT SWALLOW. [g]

 

Colostrum powder – bovine

In listed medicines

·     Products containing bovine colostrum powder contain lactose and cow’s milk proteins.

·     This product is not suitable for use in children under the age of 12 months except on professional health advice.

Creatine

In listed medicines

·     Seek professional advice before long term use.

Creatine monohydrate

In listed medicines

·     Seek professional advice before long term use.

Creatine phosphate

In listed medicines

·     Seek professional advice before long term use.

Diclofenac

(Entry 1 of 2)

NB: entry amended in Schedule 2

 

When included in a Schedule to the SUSMP and:

a.        indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing diclofenac or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Diclofenac

(Entry 2 of 2)

NB: entry amended in Schedule 2

 

When included in a Schedule to the SUSMP and:

a.        NOT indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to diclofenac or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing diclofenac or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

Diethyltoluamide (DEET)

All, including where present as an excipient

·     WARNING - May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time.

Diphenoxylate

 

NB: entry amended in Schedule 2

 

In medicines for oral use

·     either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.

or

·         This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

·     Do not give to children under 12 years of age.

·     either

·         Do not use beyond 48 hours or in pregnancy or lactation except on doctor’s advice.

or

·         If the condition persists after two days of treatment seek medical advice as soon as possible.

and

·         Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist.

Econazole

In preparations for vaginal use   

·     Seek medical advice before first course of treatment.

·     See a doctor if you are pregnant or diabetic.

·     See a doctor if no better after [Insert number of days as per approved Product Information] days.

·     See a doctor if problem returns.

Eucalyptus oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 25 per cent of eucalyptus oil; and

b.       packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

 

Eugenol

(Entry 1 of 2)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.     in preparations containing more than 25 per cent of eugenol; and

b.     packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

 

Eugenol

(Entry 2 of 2)

When included in a Schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes.

·     DO NOT SWALLOW. [g]

 

Fallopia multiflora (previous name Polygonum multiflorum)

NB: entry amended in Schedule 2

In listed medicines

·   either

-            Warning: Polygonum multiflorum may harm the liver in some people.

    or

-            Warning: Fallopia multiflora may harm the liver in some people.

·   Use under the supervision of a healthcare professional.

Famotidine

In medicines for oral use

·     CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.

·     If symptoms persist or recur within two weeks of completing the course, consult a doctor.

Fluconazole

NB: entry amended in Schedule 2

In medicines for oral use

·     See a doctor if no better after [Insert number of days as per approved Product Information] days.

Fluorides

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in dental hygiene products (other than pastes, powders or gels for the cleaning of teeth); and

b.       the preparation contains 220 milligrams per kilogram or 220 milligrams per litre or less of fluoride ion; and

c.        in packs containing not more than 120 milligrams total fluoride, fitted with a child-resistant closure

·     Do not swallow.

·     Do not use [this product/insert name of product] in children 6 years of age or less.

Flurbiprofen

NB: entry amended in Schedule 2

 

When included in a schedule to the SUSMP

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to flurbiprofen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing flurbiprofen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     either

-        Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

     or

-        Do not use during the last three months of pregnancy.

       and

-        Unless a doctor has told you to, do not use [this product/insert name of product] if you are pregnant.

Glucosamine hydrochloride

In listed medicines, when derived from a marine source

·     Derived from seafood.

Glucosamine sulfate

In listed medicines, when derived from a marine source

·     Derived from seafood.

Glucosamine sulfate potassium chloride complex

(Entry 1 of 2)

In listed medicines, when derived from a marine source

·     Derived from seafood.

Glucosamine sulfate potassium chloride complex

(Entry 2 of 2)

In listed medicines for oral use

·     Keep out of reach of children.

·     Contains [amount of potassium] potassium.

·     If you have kidney disease or are taking heart or blood pressure medicines, consult your doctor or pharmacist before use.

Glucosamine sulfate sodium chloride complex

In listed medicines, when derived from a marine source

·     Derived from seafood.

Hexachlorophane

In preparations for skin cleansing purposes containing 3 per cent or less of hexachlorophane

·   For external washing only.

·   Rinse skin thoroughly after use.

High selenium yeast

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Honey

In listed medicines

·     Not suitable for infants under 12 months.

Hydrocortisone

(Entry 1 of 2)

In preparations for dermal use  

·     CAUTION - Do not use for children under 2 years old unless a doctor has told you to.

·     Do not use in the eyes.

·     Do not use for acne.

·     Do not use under waterproof bandages unless a doctor has told you to.

·     Do not use for more than 7 days unless a doctor has told you to.

Hydrocortisone

(Entry 2 of 2)

For topical rectal use when included in Schedule 3 to the SUSMP

·     CAUTION - Do not use for children under 2 years old unless a doctor has told you to.

·     Do not use for more than 7 days unless a doctor has told you to.

Hydrofluoric acid (including mixtures that generate hydrofluoric acid)

(Entry 1 of 2)

In Schedule 5 to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive.

Avoid contact with eyes.

Avoid contact with skin.

·     DO NOT SWALLOW. [g]

 

Hydrofluoric acid (including mixtures that generate hydrofluoric acid)

(Entry 2 of 2)

In Schedule 6 or Schedule 7 to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Highly corrosive

Contact with eyes even for short periods can cause blindness

Causes severe burns, which are not likely to be immediately painful or visible

Avoid contact with eyes

Avoid contact with skin

Wear protective gloves when mixing or using

Avoid breathing [dust/vapour/spray mist]

Obtain a supply of calcium gluconate gel.

 

Hydrogen peroxide

(Entry 1 of 3)

In concentrations of more than 3 per cent up to 10 per cent

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Irritant

Avoid contact with eyes.

·     DO NOT SWALLOW. [g]

 

Hydrogen peroxide

(Entry 2 of 3)

In concentrations of more than 10 per cent up to 20 per cent

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Irritant

Attacks eyes - protect eyes when using.

 

Hydrogen peroxide

(Entry 3 of 3)

In concentrations of more than 20 per cent

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Attacks eyes - protect eyes when using

Avoid contact with skin.

·   Corrosive.

Hydroquinone

NB: entry amended in Schedule 2

 

In Schedule 2 to the SUSMP

·     WARNING - If a pigmented spot or mole has recently become darker, changed colour, become enlarged or itchy, or bleeds, do not use this product, see your doctor immediately.

·     Do not use on children.

·     Do not use near the eyes.

·     Mild irritation may occur; stop use if it becomes severe.

·     If fading is not evident in three months, seek doctor’s advice.

8-Hydroxyquinoline (including salts and derivatives)

In preparations for internal use

·     Do not take for periods longer than four weeks except on medical advice.

Hypericum perforatum

In listed medicines for oral use

·     St John’s Wort affects the way many prescription medicines work, including oral contraceptives.

·     Consult your doctor.

Ibuprofen

(Entry 1 of 4)

 

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        the preparation is for oral use; and

b.       the preparation is indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.

·     Unless a [doctor / doctor or pharmacist] has told you to, do not use [this product/insert name of product] with other medicines containing ibuprofen, aspirin or other anti-inflammatory medicines, or other medicines that you are taking regularly.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Ibuprofen

(Entry 2 of 4)

 

NB: entry amended in Schedule 2

 

 

For the purpose of exclusion from the schedules to the SUSMP, when:

a.        the preparation is for oral use; and

b.       the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.

·     Unless a [doctor / doctor or pharmacist] has told you to, do not use [this product/insert name of product] with other medicines containing ibuprofen, aspirin or other anti-inflammatory medicines, or other medicines that you are taking regularly.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 6 years of age or less.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you are aged 65 years or over.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

Ibuprofen

(Entry 3 of 4)

 

NB: entry amended in Schedule 2

 

When included in a schedule  to the SUSMP and

a.           the preparation is indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing ibuprofen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Ibuprofen

(Entry 4 of 4)

 

NB: entry amended in Schedule 2

 

 

When included in a schedule to the SUSMP and

a.          the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ibuprofen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing ibuprofen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

Iodine

NB: entry amended in Schedule 2

 

In preparations for internal use containing 300 micrograms or more of iodine per recommended daily dose

·     CAUTION - Total iodine intake may exceed recommended level when taking this preparation.

·     WARNING - Contains iodine - do not take when pregnant except on physician’s advice.

 

Ipratropium bromide

In metered aerosols

·     This preparation should be part of an overall treatment plan regularly assessed with your doctor.

Ketoprofen

(Entry 1 of 2)

NB: entry amended in Schedule 2

 

In preparations for oral use indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ketoprofen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing ketoprofen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Ketoprofen

(Entry 2 of 2)

NB: entry amended in Schedule 2

 

In preparations for oral use that are NOT indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to ketoprofen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing ketoprofen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

Kunzea ambigua

NB: entry amended in Schedule 2

In listed medicines when the preparation is “essential oil”

·     For external use only.

·     Keep out of reach of children.

·     Not to be applied undiluted to the skin except on the advice of a health care practitioner.

Lactoferrin – bovine

In listed medicines

·     Derived from cow’s milk.

Larrea tridentata

In listed medicines

·     Warning: Chaparral may harm the liver in some people.

·     Use only under the supervision of a healthcare professional.

Lemon oil

 

For the purpose of exclusion from the schedules to the SUSMP

·     Application to skin may increase sensitivity to sunlight.

Levocabastine

(Entry 1 of 2)

In eye or nasal preparations containing 0.5 milligrams per millilitre or less of levocabastine

·     Do not use if pregnant.

Levocabastine

(Entry 2 of 2)

In eye or nasal preparations containing MORE THAN 0.5 milligrams per millilitre of levocabastine

·     Do not use if pregnant.

·     either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.

or

·         This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

Lime oil

 

For the purpose of exclusion from the schedules to the SUSMP

·     Application to skin may increase sensitivity to sunlight.

Loperamide hydrochloride

NB: entry amended in Schedule 2

 

In Schedule 2 to the SUSMP

·     Do not give to children under 12 years of age.

·     either

·         Do not use beyond 48 hours or in pregnancy or lactation except on doctor’s advice.

or

·         If the condition persists after two days of treatment seek medical advice as soon as possible.

        and

·         Do not use during pregnancy or breastfeeding unless advised by your doctor or pharmacist.

Marjoram oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of marjoram oil; and

b.       packed in containers having a nominal capacity of 50 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Mefenamic acid

NB: entry amended in Schedule 2

 

When the preparation is indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to mefenamic acid or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing mefenamic acid or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing mefenamic acid, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Melaleuca oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 25 per cent of melaleuca oil; and

b.       when packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Methoxamine

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Miconazole

In preparations for vaginal use   

·     Seek medical advice before first course of treatment.

·     See a doctor if you are pregnant or diabetic.

·     See a doctor if no better after [Insert number of days as per approved Product Information] days.

·     See a doctor if problem returns.

Naphazoline

NB: entry amended in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Naproxen

(Entry 1 of 2)

 

NB: entry amended in Schedule 2

 

When the preparation is indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to naproxen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing naproxen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

Naproxen

(Entry 2 of 2)

 

NB: entry amended in Schedule 2

 

When the preparation is NOT indicated exclusively for the treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to naproxen or other anti-inflammatory medicines.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     either

-        Unless a doctor has told you to, do not use [this product/insert name of product] with other medicines containing naproxen or other anti-inflammatory medicines.

or

-        Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful.

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

Nizatidine

In Schedule 2 to the SUSMP

·     CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.

·     If symptoms persist or recur within two weeks of completing the course, consult a doctor.

Nutmeg oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of nutmeg oil; and

b.       packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Nystatin

In preparations for vaginal use   

·     See a doctor if you are pregnant or diabetic.

·     Seek medical advice before first course of treatment.

·     If getting better, keep using for [insert number of days as per approved Product Information] days.

·     See a doctor if no better after [Insert number of days as per approved Product Information] days.

·     See a doctor if problem returns.

Orange oil (bitter)

For the purpose of exclusion from the schedules to the SUSMP

·   Application to skin may increase sensitivity to sunlight.

Oxymetazoline

NB: entry amended in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Paracetamol

(Entry 1 of 2)

 

For the purpose of exclusion from the schedules to the SUSMP

·     Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

·     Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

·     If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

·     Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

Paracetamol

(Entry 2 of 2)

 

In a schedule to the SUSMP

·      

-        Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

and / or

-        Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

·     If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

·     Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

Paullinia cupana

In listed medicines

·     The goods contain caffeine.

·     Each [insert name of dosage unit] contains [insert quantity] of caffeine.

Pennyroyal oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 4 per cent of d-pulegone; and

b.       when packed in containers having a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Permanganates

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive

Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.

 

Phenol and any other homologue of phenol.

 

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes

Avoid contact with skin

·     DO NOT SWALLOW. [g]

 

Phenylalanine

In listed medicines for oral or sublingual administration, the MRDD of which contains more than 500 milligrams of phenylalanine

·     Do not use if pregnant or likely to become pregnant.

Phenylephrine

NB: see new entries in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Piper methysticum

(Entry 1 of 2)

In listed medicines for oral use containing more than 25 mg of kavalactones per dose

·     Not recommended for use by pregnant or lactating women.

·     WARNING: Not for prolonged use.

·     If symptoms persist, seek advice from a health care practitioner.

·     May harm the liver.

Piper methysticum

(Entry 2 of 2)

For the purpose of exclusion from the schedules to the SUSMP in medicines for oral use

·     Not recommended for use by pregnant or lactating women.

·     WARNING: Not for prolonged use.

·     May harm the liver.

Podophyllin

(Entry 1 of 2)

In liquid preparations other than preparations specifically for use on the anal or genital areas

·     WARNING - Do not use on face or on anal or genital areas except on doctor’s advice.

Podophyllin

(Entry 1 of 2)

In solid or semi-solid preparations other than preparations specifically for use on the anal or genital areas.

·     WARNING - Do not use on face or on anal or genital areas.

Podophyllotoxin

(Entry 1 of 2)

In liquid preparations other than preparations specifically for use on the anal or genital areas

·     WARNING - Do not use on face or on anal or genital areas except on doctor’s advice.

Podophyllotoxin

(Entry 2 of 2)

In solid or semi-solid preparations other than preparations specifically for use on the anal or genital areas

·     WARNING - Do not use on face or on anal or genital areas.

Potassium hydroxide

(Entry 1 of 3)

When included in a schedule to the SUSMP, in preparations containing 0.5 per cent OR LESS of potassium hydroxide

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Irritant

Avoid contact with eyes

Avoid contact  with skin

Wash hands after use.

·     DO NOT SWALLOW. [g]

Potassium hydroxide

(Entry 2 of 3)

 

When included in a schedule to the SUSMP, in solid preparations containing MORE THAN 0.5 per cent of potassium hydroxide

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive

May produce severe burns

Attacks skin and eyes

Wear eye protection when mixing or using

Wear protective gloves when mixing or using

Do not mix with hot water.

Potassium hydroxide

(Entry 3 of 3)

When included in a schedule  to the SUSMP, in liquid preparations containing MORE THAN 0.5 per cent of potassium hydroxide

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive

May produce severe burns

Attacks skin and eyes

Wear eye protection when mixing or using

Wear protective gloves when mixing or using.

Propolis

(Entry 1 of 2)

In listed medicines for internal use

·     WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs - discontinue use.

Propolis

(Entry 2 of 2)

In listed medicines for external use

·     WARNING: Propolis may cause skin irritation. Test before use.

Pyridoxal 

(see also Vitamins)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when in SINGLE‑INGREDIENT preparations containing more than 50 milligrams of pyridoxal per recommended daily dose

either

·     WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

or

·     WARNING – This [medication]/ [product contains pyridoxal which] may be dangerous when used in large amounts or for a long time.

Pyridoxal 

(see also Vitamins)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when in MULTI‑INGREDIENT preparations containing more than 50 milligrams of pyridoxal per recommended daily dose

either

·     WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6.

or

·     WARNING – This [medication]/ [product contains pyridoxal which] may be dangerous when used in large amounts or for a long time.

 

Pyridoxine

(see also Vitamins)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when in SINGLE‑INGREDIENT preparations containing more than 50 milligrams of pyridoxine per recommended daily dose

either

·     WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible.

or

·     WARNING – This [medication]/ [product contains pyridoxine which] may be dangerous when used in large amounts or for a long time.

 

Pyridoxine

(see also Vitamins)

NB: entry amended in Schedule 2

 

For the purpose of exclusion from the schedules to the SUSMP when in MULTI‑INGREDIENT preparations containing more than 50 milligrams of pyridoxine per recommended daily dose

either

·     WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. Contains vitamin B6.

or

·     WARNING – This [medication]/ [product contains pyridoxine which] may be dangerous when used in large amounts or for a long time.

Pyrithione zinc

For the purpose of exclusion from the schedules to the SUSMP when in shampoos containing 2 per cent or less of pyrithione zinc

either

·     Keep out of eyes

or

·     If in eyes, rinse well with water.

Ranitidine

In medicines for oral use

·     CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.

·     If symptoms persist or recur within two weeks of completing the course, consult a doctor.

Royal jelly

NB: Entry amended in Schedule 2

In listed medicines

·   Not to be taken by asthma and allergy sufferers. [k] [l]

·     This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities – especially in asthma and allergy sufferers.

Safrole

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes.

Sage oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 4 per cent of thujone; and

b.       packed in containers having a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·     KEEP OUT OF REACH OF CHILDREN.

·     NOT TO BE TAKEN.

Salbutamol

In metered aerosols or in dry powder formulations

·     This preparation should be part of an overall treatment plan regularly assessed with your doctor.

Sassafras oil

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes.

Selenium yeast – high

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Selenocysteine

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Selenomethionine

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Shark cartilage

In listed medicines

·     Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice.

Silver

(see also Silver salts)

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in chewing gum containing 5 milligrams or less of silver per dosage unit; or

b.       in solutions for oral use containing 0.3 per cent or less of silver

·     Overuse may stain skin or mouth.

Silver salts

(see also Silver)

In smoking deterrents

·     WARNING - Overuse may stain the skin or mouth.

Sodium fluoride

In preparation for oral ingestion when in Schedule 2 of the SUSMP

·     Use of this product is not necessary in areas supplied with fluoridated water.

Sodium hydroxide

(Entry 1 of 3)

When included in a schedule to the SUSMP in preparations containing 0.5 per cent OR LESS of sodium hydroxide

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Irritant

Avoid contact with eyes

Avoid contact with skin

Wash hands after use.

·     DO NOT SWALLOW. [g]

Sodium hydroxide

(Entry 2 of 3)

When included in a schedule to the SUSMP in solid preparations containing MORE THAN 0.5 per cent of sodium hydroxide

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive

May produce severe burns

Attacks skin and eyes

Wear eye protection when mixing or using

Wear protective gloves when mixing or using

Do not mix with hot water.

Sodium hydroxide

(Entry 3 of 3)

When included in a schedule to the SUSMP in liquid preparations containing MORE THAN 0.5 per cent of sodium hydroxide

·     Either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Corrosive

May produce severe burns

Attacks skin and eyes                                                                                 

Wear eye protection when mixing or using

Wear protective gloves when mixing or using.

Sodium selenate

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Sodium selenite

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses.

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

Sodium sulfate

In listed medicines

·     This preparation may have a laxative effect.

(S)-S-Adenosylmethionine

In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts

·     Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.

Star anise oil

 

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of star anise oil; and

b.       packed in containers having a nominal capacity of 50 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Sugar cane wax alcohols

In listed medicines

·     Not recommended for use by pregnant or lactating women.

Symphytum spp.

In Schedule 5 to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Do not use on broken skin

Do not use under occlusive dressing

·     DO NOT SWALLOW. [g]

Terbutaline

In metered aerosols

·     This preparation should be part of an overall treatment plan regularly assessed with your doctor.

Tetrahydrozoline

NB: entry amended in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Thyme oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of thyme oil; and

b.       packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·     KEEP OUT OF REACH OF CHILDREN.

Tramazoline

NB: entry amended in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Triamcinolone

In topical preparations for the treatment of mouth ulcers

Either

·     See a [doctor / doctor or dentist] if no better after [Insert number of days as per approved Product Information] days.

or

·     If symptoms persist beyond 5 days consult a [doctor / doctor or dentist].

Tymazoline

 

In nasal decongestant preparations for topical use

·   If congestion persists, consult your doctor or pharmacist.

Ubidecarenone

In listed medicines

·     Not to be taken if on warfarin therapy, without medical advice.

Vitamin A

(see also Vitamins)

               

In preparations for internal use that are labelled for adult use, containing MORE THAN:

a.        33 micrograms retinol equivalents of vitamin A per dosage unit of a divided preparation; or

b.       33 micrograms retinol equivalents of vitamin A per gram of an undivided preparation

·     The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.

·     WARNING – When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects. [c],

·     If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist [c],

 

 

Vitamins

(see also:

Pyridoxal

Pyridoxine

Vitamin A)

In listed medicines

Either

·     Vitamins can only be of assistance if the dietary vitamin intake is inadequate.

or

·     Vitamin supplements should not replace a balanced diet.

Xylometazoline

NB: entry amended in Schedule 2

In nasal decongestant preparations for topical use

·     If congestion persists, consult your doctor or pharmacist.

Yeast – high selenium

NB: Entry amended in Schedule 2

In listed medicines

·     This product contains selenium which is toxic in high doses

·     A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.

 

Zinc chloride

When included in a schedule  to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes

Avoid contact with skin.

Zinc compounds

In preparations for internal use with a recommended daily dose of more than 25 milligrams of zinc

either

·     WARNING - This medication may be dangerous when used in large amounts or for a long period.

or

·     WARNING - Contains zinc, which may be dangerous when used in large amounts or for a long period.

Zinc sulfate

When included in Schedule 6 to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes

Avoid contact with skin.

Zingiber officinale

In listed medicines:

a.        when the extraction ratio is 25:1 or higher; and

b.       when the equivalent dry weight per dosage unit is 2 grams or higher

·     Individuals taking anticoagulants should seek medical advice before taking this product.

·     Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this product.

 

 

 

 

 


Schedule 2

 

 

Required Advisory Statements for Medicine Labels No. 2

 

(section 5)

 

 


 

Schedule 2    

Required Advisory Statements for Medicine Labels No. 2

Advisory statements

Where a medicine:

3)       includes a substance described in Column 1 of Table 1:Medicines to Which Advisory Statements Apply (‘the table’), below; and

4)       meets the condition(s) described in Column 2 of the table;

 

the statement(s) set out in Column 3 of the table must be contained on the labels of the medicine in accordance with the Labelling Order, in a manner that is compliant with any applicable presentation requirement(s) set out below  (the requirements are indicated in the table by the presence of the applicable alphabetical in square brackets, next to the statement or, in the case of a requirement to use upper case and/or bold face, by use of upper case and/or bold face letters in the statement itself).

Unless otherwise specified, the requirements apply only if the substance is included in the medicine as an active ingredient.

Permitted variation and combination of statements

The wording of the statements specified in this document may be varied provided that the intent is not changed.

Where more than one statement is required, they may be combined to form simple sentences where appropriate, provided that the intent is not changed and that any additional requirements are also met.

Additional presentation requirements for some advisory statements

In some cases, additional requirements apply to advisory statements, such as font, letter size etc.   Where such additional requirements apply, they are indicated in Column 3 of Table 1 below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper case and/or bold face, by use of  upper case and/or bold face letters in the statement itself.  The meaning of the letters is set out below:

 [c]: Statement(s) must be included at the beginning of the directions for use on the label.

 [f]:  Statement(s) must be included on the label written:

(i)    on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN”; and

(ii)   in bold-face sanserif capital letters of uniform thickness; and

(iii)  in letters as least four tenths the height of the letters used for the signal heading; and

(iv) with nothing written on the same line.

[g]: Statement(s), written in sanserif capital letters, must be included on the main label or as part of the directions for use.

[k]: Statement(s) must be printed in type of 3 mm height or larger.

[l]: Statement(s) must be printed on the front of the goods.


 

 

Table 1: Medicines to which advisory statements apply

Column 1

Substance(s)

 Column 2

Conditions

Column 3

Required statement(s)

Acetone

In concentrations greater than 75 per cent

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]

·   SAFETY DIRECTIONS

Avoid contact with eyes 

Avoid contact with skin

Avoid breathing [vapour/spray mist] 

·   DO NOT SWALLOW. [g]

Actaea racemosa

 

In listed medicines

·   Warning: In very rare cases, Black cohosh has been associated with liver failure.

·   If you are experiencing yellowing of the skin or whites of the eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using this product and see your doctor.

Activated charcoal

In listed medicines

·   Products containing activated charcoal should be used with caution in children since it may interfere with the absorption of nutrients.

·   This substance may interact with other medicines.

·   Activated charcoal is not recommended for long-term use.

Ademetionine 

In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts

·   Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.

(S)-S-Adenosylmethionine

In listed medicines, in the form of sulfate salts, tosylate salts or mixed sulfate and tosylate salts

·   Individuals who are using prescription antidepressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner.

Alclometasone

When included in Schedule 3 to the SUSMP

 

·   CAUTION - Do not use for children under 2 years old unless a doctor has told you to. 

·   Do not use in the eyes.

·   Do not use for acne.

·   Do not use under waterproof bandages unless a doctor has told you to.

·   Do not use for more than 7 days unless a doctor has told you to. 

Alpha casozepine enriched hydrolysed milk protein

In listed medicines for oral ingestion

·   Derived from cow’s milk.

·   This product is not suitable for use in children under the age of 12 months except on professional health advice.

Alpha hydroxy acids, including:

·       citric acid and other fruit acids

·       glycollic acid

·       lactic acid

When used as active ingredients in preparations for topical use

·   This product may make your skin more sensitive to sunlight and other sources of UV light.

·   Sun exposure should be limited by using a sunscreen and by wearing protective clothing.

·   Transient stinging or irritation may occur when using this product.  If irritation persists, discontinue use.

·   If you have sensitive skin, test this product on a small area of skin before applying it to a large area.

·   Not recommended for use on children and infants.

Amethocaine

(Entry 1 of 2)

When included in Schedule 2 to the SUSMP and for dermal use

·   Do not apply to large areas of the body, except on the advice of a healthcare practitioner.

·   If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

Amethocaine

(Entry 2 of 2)

For the purpose of exclusion from the schedules of the SUSMP when in dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances

·   If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

Ammonia and ammonium salts, including

·      ammonium chloride

·      ammonium bicarbonate

·      ammonium carbonate

(Entry 1 of 2)

In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years

·   Do not give to children under 12 years of age.

Ammonia and ammonium salts, including

·      ammonium chloride

·      ammonium bicarbonate

·      ammonium carbonate

(Entry 2 of 2)

In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·   Do not give to children under ‘x’ years of age.

·   either (if ‘x’ is 11)

-    Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.  

or (if ‘x’ is 6, 7, 8, 9 or 10)

-    Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.  

Anise oil

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 50 per cent of anise oil; and

b.       packed in containers having a nominal capacity of 50 millilitres or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN. 

Antihistamines 

(Entry 1 of 5)

When included in a schedule to the SUSMP and NOT separately specified in the table and NOT:

a.        dermal, ocular or  paediatric preparations; or

b.       oral preparations of desloratadine, loratadine or fexofenadine; or

c.        nasal preparations of azelastine.

either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.  

      or

·         This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

 

Antihistamines

(Entry 2 of 5)

In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years

·     either

  • This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.  

or

  • This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

·   Do not give to children under 12 years of age.

Antihistamines

(Entry 3 of 5)

In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·     either

  • This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.  

or

  • This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

·   Do not give to children under ‘x’ years of age. 

·   either (if ‘x’ is 11)

-    Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.  

or (if ‘x’ is 6, 7, 8, 9 or 10)

-    Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. 

Antihistamines

(Entry 4 of 5)

In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·   Do not give to children under ‘x’ years of age. 

·   either (if ‘x’ is 11)

-    Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.  

or (if ‘x’ is 6, 7, 8, 9 or 10)

-    Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.   

Antihistamines

(Entry 5 of 5),

including:

-Diphenhydramine

-Doxylamine

-Promethazine

When indicated for short term use in insomnia

·   Not recommended for use by pregnant or breastfeeding women.

·   Do not take this medicine for more than a few days.

·   This product should be taken on medical or pharmacist advice.

·   This preparation is to aid sleep.  Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

Arginine

In listed medicines

·   This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa, vagina or rectum.

Aspartame

When for oral ingestion and included in medicines as an active or excipient ingredient

·   Phenylketonurics are warned that this product contains aspartame (phenylalanine).  

Aspirin

(Entry 1 of 7)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        each dosage unit contains MORE than 100 milligrams of aspirin;  and

b.       the preparation is NOT indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation 

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·   See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 2 of 7)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        each dosage unit contains MORE  than 100 milligrams of aspirin; and

b.       the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation

 

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

Aspirin

(Entry 3 of 7)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.     each dosage unit contains 100 milligrams OR LESS of aspirin; and

b.     the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation

 

·   For use under medical supervision only

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·   See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 4 of 7)

 

When included in a schedule to the SUSMP and:

a.     the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

b.     in sustained release preparations containing 650 milligrams or more of aspirin

·   For use under medical supervision only. 

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·   See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 5 of 7)

 

When included in a schedule to the SUSMP and:

a.     the preparation IS indicated exclusively for treatment of dysmenorrhoea; and

b.       NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.     NOT in combination with other therapeutically active substances (other than effervescent agents)

 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·   See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Aspirin

(Entry 6 of 7)

 

When included in a schedule to the SUSMP and:

a.     in  combination with other therapeutically active substances (other than effervescent agents); and

b.      NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.     the preparation is NOT indicated:

   i.     for   the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

 ii.     exclusively for treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

Aspirin

(Entry 7 of 7)

 

When included in a schedule to the SUSMP and:

a.        NOT in combination with other therapeutically active substances (other than effervescent agents); and

b.       NOT in sustained release preparations containing 650 milligrams or more of aspirin; and

c.        the preparation is NOT indicated:

i.   for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; or

ii.              exclusively for treatment of dysmenorrhoea

·     Do not use [this product/insert name of product] during the first 6 months of pregnancy, except on doctor’s advice   Do not use at all during the last 3 months of pregnancy. 

·     Do not use [this product/insert name of product] if you have a stomach ulcer.

·     Do not use [this product/insert name of product] if you are allergic to aspirin or other anti-inflammatory medicines.

·     If you get an allergic reaction, stop taking and see your doctor immediately.

·     Unless a doctor has told you to, do not use [this product/insert name of product] for more than a few days at a time.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children under 12 years of age.

·     Unless a doctor has told you to, do not use [this product/insert name of product] in children 12 to 16 years of age with or recovering from chicken pox, influenza or fever.

·     Unless a doctor has told you to, do not use [this product/insert name of product] if you have asthma.

·     Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·   See a doctor before taking [this product/insert name of product] for thinning the blood or for your heart.

Atropa belladona

In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness

·   If the condition persists after two days of treatment, seek medical advice as soon as possible.

·    

 

Atropine

In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness

·   If the condition persists after two days of treatment, seek medical advice as soon as possible.

Azadirachta indica (neem)

(Entry 1 of 2)

When:

a.        included in listed medicines; or

b.       for the purpose of exclusion from the schedules to the SUSMP when in preparations for dermal use and in a container fitted with a child resistant closure

·   Not to be taken.

·   Keep out of reach of children. 

·   Do not use if pregnant or likely to become pregnant. 

 

Azadirachta indica including its extracts and derivatives

(Entry 2 of 2)

When included in Schedule 6 to the SUSMP

·  Do not use if pregnant or likely to become pregnant.  

 

Azelastine

In preparations for topical ophthalmic or nasal administration

·   If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

Backhousia citriodora

In listed medicines

·   Not recommended for use by children aged 12 years or under. 

·   Not recommended for use by pregnant or lactating women. 

·   If skin irritation occurs, discontinue use.

Basil oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations or oils containing more than 5 per cent of methyl chavicol; and

b.       packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.  

Bay oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations containing more than 25 per cent of bay oil; and

b.       packed in containers having:

  i.          a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·   KEEP OUT OF REACH OF CHILDREN.  

·   NOT TO BE TAKEN 

 

Benzocaine

(Entry 1 of 3)

In dermal preparations containing MORE than 2 per cent of total local anaesthetic substances

·   Do not apply to large areas of the body, except on the advice of a healthcare practitioner.

·   If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

Benzocaine

(Entry 2 of 3)

In dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances

·   If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.

Benzocaine

(Entry 3 of 3)

In lozenges

·   Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth. 

·   Do not give to children under 6 years of age, unless recommended by a doctor, pharmacist or dentist.

Benzoyl peroxide

In Schedule 2 to the SUSMP

 

·   Keep from eyes, lips, mouth and sensitive areas of the neck.  

·   If excessive swelling, irritation, redness or peeling occurs, discontinue use.  

·   If these persist, consult a physician.  

·   Avoid excessive exposure to sunlight and other sources of ultra violet light.  

Benzydamine

 

In preparations for topical use or dermal use

·   Do not use [this product/insert name of product] if you are allergic to benzydamine or other anti-inflammatory medicines.  

·   If you get an allergic reaction, stop taking and see your doctor immediately.  

Bergamot oil

For the purpose of exclusion from the schedules to the SUSMP; or when included in a schedule to the SUSMP

·   Application to skin may increase sensitivity to sunlight.  

Bovine colostrum powder

In listed medicines

·   Products containing bovine colostrum powder contain lactose and cow’s milk proteins.

·   This product is not suitable for use in children under the age of 12 months except on professional health advice.

Bovine lactoferrin

In listed medicines

·   Derived from cow’s milk.

Bovine whey IG-rich fraction

In listed medicines for oral ingestion

·   Derived from cow’s milk.

·   This product is not suitable for use in children under the age of 12 months except on professional health advice.

Bromhexine

(Entry 1 of 2)

In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years

·   Do not give to children under 12 years of age. 

Bromhexine

(Entry 2 of 2)

In oral preparations indicated for cough, cold or flu which include dosage instructions for children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·   Do not give to children under ‘x’ years of age.

·   either (if ‘x’ is 11)

-            Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner . 

or (if ‘x’ is 6, 7, 8, 9 or 10)

-            Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. 

Brompheniramine  

(Entry 1 of 3)

In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years

·     either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.  

or

·         This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

·   Do not give to children under 12 years of age.

Brompheniramine  

(Entry 2 of 3)

In oral preparations indicated for cough, cold or flu which include dosage instructions for adults and children aged from ‘x’ to 11 years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·     either

·         This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.  

or

  • This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.

·   Do not give to children under ‘x’ years of age. 

·   either (if ‘x’ is 11)

-    Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.  

or (if ‘x’ is 6, 7, 8, 9 or 10)

-    Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.  

Brompheniramine  

(Entry 3 of 3)

In oral preparations indicated for cough, cold or flu which only include dosage instructions for children aged from ‘x’ years (where ‘x’ is 6, 7, 8, 9, 10 or 11)

·   Do not give to children under ‘x’ years of age. 

·   either (if ‘x’ is 11)

-    Do not give to children aged 11 years, except on the advice of a doctor, pharmacist or nurse practitioner.  

or (if ‘x’ is 6, 7, 8, 9 or 10)

-    Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.  

Butoconazole

In  preparations  for vaginal use

·   Do not use if you are pregnant.  

·   See a doctor before use if you are diabetic.  

·   Seek medical advice before first course of treatment.  

·   See a doctor if no better after [Insert number of days as per approved Product Information] days.  

·   See a doctor if problem returns.  

Caffeine

(Entry 1 of 2)

In listed medicines, except medicines containing less than 1 milligram of caffeine in the MRDD:

a.        for oral or sublingual administration; and

b.       the MRDD of which contains 10 milligrams OR LESS of caffeine or less; and

c.        when the caffeine is from a herbal source

·   The recommended dose of this medicine provides small amounts of caffeine.

Caffeine

(Entry 2 of 2)

 

In listed medicines:

a.        for oral or sublingual administration; and

b.       the MRDD of which contains MORE THAN 10 milligrams of caffeine; and

c.        when the caffeine is from a herbal source

·   Contains [amount of caffeine in milligrams] mg of caffeine.

Cajuput oil

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in preparations or oils containing more than 25 per cent of cajuput oil; and

b.       packed in containers having:

        i.    a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·   KEEP OUT OF REACH OF CHILDREN.  

·   NOT TO BE TAKEN.  

Calcium sodium caseinate

In listed medicines

either

·           Derived from cow’s milk.

or

·           Contains cow’s milk protein.

Camphor

(Entry 1 of 3)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        included as a natural component in essential oils containing greater than 2 5 per cent of camphor but 10 per cent or less of camphor; and

b.       packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.  

·   NOT TO BE TAKEN.  

·   Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist.

 

Camphor

(Entry 2 of 3)

 

For the purpose of exclusion from the schedules to the SUSMP when:

a.        in essential oils when the camphor is present as a natural component of the oil; and

b.       packed in containers having:

  i.          a nominal capacity of 15 millilitres or less, fitted with a restricted flow insert; or

       ii.   a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert and child-resistant closure

·   KEEP OUT OF REACH OF CHILDREN.  

·   NOT TO BE TAKEN.  

·   Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist.

 

Camphor

(Entry 3 of 3)

When:

a.        included in a schedule to the SUSMP, and

b.     not in block, ball or pellet form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents.

·     either

-            READ SAFETY DIRECTIONS [f]

or

-            READ SAFETY DIRECTIONS BEFORE OPENING AND USING.  [f]

·     SAFETY DIRECTIONS

Can be fatal to children if sucked or swallowed. 

 Avoid contact with eyes.  

 

Canarium indicum 

In listed medicines

·   This product contains material derived from nuts.

Carthamus tinctorius

In listed medicines

·   Do not use if pregnant or likely to become pregnant.

Cassia oil

When included in a schedule to the SUSMP

·     either

-            READ SAFETY DIRECTIONS [f]

or