1.  The whole of this instrument

1 January 2022.

1 January 2022

1

[c]

Statements must be included at the beginning of the directions for use on the label

2

[f]

Statements must be included on the label written:

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

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

(c)     in letters at least four tenths the height of the letters used for the signal words; and

(d)     with no other statement written on the same line

3

[g]

Statements, written in sanserif capital letters, must be included on the main label or as part of the directions for use

1

Schedule 2

for any purpose

PHARMACY MEDICINE

2

Schedule 3

for any purpose

PHARMACIST ONLY MEDICINE

3

Schedule 4

for human use

PRESCRIPTION ONLY MEDICINE

4

Schedule 5

for any purpose

CAUTION

5

Schedule 6

for any purpose

POISON

6

Schedule 7

for any purpose

DANGEROUS POISON

7

Schedule 8

for any purpose

CONTROLLED DRUG

1

Alclometasone

When included in 3 to the current Poisons Standard

·   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 Schedule told you to.

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

2

Alimemazine (trimeprazine)

Entry 1 of 2

In oral medicines that are NOT indicated for cough cold or flu, which include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

·        If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

3

Alimemazine (trimeprazine)

Entry 2 of 2

In oral medicines that are NOT indicated for cough cold or flu, that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

·        This medication may cause drowsiness.

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

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

·        If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

4

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.

5

Amethocaine (tetracaine)

(Entry 1 of 2)

When included in Schedule 2 to the current Poisons Standard 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.

6

Amethocaine (tetracaine)

(Entry 2 of 2)

For the purpose of exclusion from the schedules to the current Poisons Standard when in dermal preparations containing 2% OR LESS of total local anaesthetic substances

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

7

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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

8

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.

·  If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

9

Anise oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·         in preparations containing more than 50% of anise oil; and

·         packed in containers having a nominal capacity of 50 mL or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.

10

Antihistamines

(Entry 1 of 5)

including:

·  Alimemazine (trimeprazine)

·  Brompheniramine

·  Chlorphenamine

·  Dexchlorpheniramine

·  Diphenhydramine

·  Doxylamine

·  Pheniramine

·  Promethazine

·  Triprolidine

when NOT separately specified in this table

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

·        (for alimemazine and promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

11

Antihistamines

(Entry 2 of 5)

including:

·  Alimemazine (trimeprazine)

·  Brompheniramine

·  Chlorphenamine

·  Dexchlorpheniramine

·  Diphenhydramine

·  Doxylamine

·  Pheniramine

·  Promethazine

·  Triprolidine

when NOT separately specified in this table

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

·        (for alimemazine and promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

12

Antihistamines

(Entry 3 of 5)

including:

·  Brompheniramine

·  Chlorphenamine

·  Dexchlorpheniramine

·  Diphenhydramine

·  Doxylamine

·  Pheniramine

·  Promethazine

·  Triprolidine

when NOT separately specified in this table

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

·    (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

13

Antihistamines

(Entry 4 of 5)

including:

·  Brompheniramine

·  Chlorphenamine

·  Dexchlorpheniramine

·  Diphenhydramine

·  Doxylamine

·  Pheniramine

·  Promethazine

·  Triprolidine

when NOT separately specified in this table

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

·   (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

14

Antihistamines

(Entry 5 of 5)

including:

·  Diphenhydramine

·  Doxylamine

·  Promethazine

In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2)

(Note: Antihistamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Antihistamines (Entry 2 of 5))

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

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

·   If breastfeeding, consult a doctor or pharmacist before use.

·   (for promethazine only) If pregnant or likely to become pregnant, consult a doctor or pharmacist before use.

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

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

15

Aspartame

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

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

16

Aspirin

(Entry 1 of 3)

When NOT in combination with other therapeutically active substances (other than effervescent agents), or indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation

·     Do not use if you have a stomach ulcer.

·     Do not use 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 if you have asthma.

·     Unless a doctor has told you to, do not use in children under 12 years of age.

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

·     Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·     Do not use during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Unless a doctor has told you to, do not use for more than a few days at a time.

·   See a doctor before taking for thinning the blood or for your heart.

17

Aspirin

(Entry 2 of 3)

When 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 if you have a stomach ulcer.

·       Do not use 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 if you have asthma.

·       Unless a doctor has told you to, do not use in children under 12 years of age.

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

·       Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·       Do not use during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·       See a doctor before taking for thinning the blood or for your heart.

18

Aspirin

(Entry 3 of 3)

When included in a schedule to the current Poisons Standard and in combination with other therapeutically active substances (other than effervescent agents)

·     Do not use if you have a stomach ulcer.

·     Do not use 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 if you have asthma.

·     Unless a doctor has told you to, do not use in children under 12 years of age.

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

·     Unless advised by your doctor or pharmacist, do not use with other products containing aspirin or anti-inflammatory medicines or with medicines that you are taking regularly.

·     Do not use during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·     Unless a doctor has told you to, do not use for more than a few days at a time.

19

Atropa belladona

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

20

Atropine

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

21

Azadirachta indica (neem)

(Entry 1 of 2)

For the purpose of exclusion from the schedules to the current Poisons Standard 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.

22

Azadirachta indica including its extracts and derivatives

(Entry 2 of 2)

When included in Schedule 6 to the current Poisons Standard

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

23

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.

24

Basil oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations or oils containing more than 5% of methyl chavicol; and

·    packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.

25

Bay oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·  in preparations containing more than 25% of bay oil; and

·  packed in containers having:

-   a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

26

Benzocaine

(Entry 1 of 4)

In dermal preparations containing MORE than 2% 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.

27

Benzocaine

(Entry 2 of 4)

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

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

28

Benzocaine

(Entry 3 of 4)

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.

29

Benzocaine

(Entry 4 of 4)

In preparations for topical oral use EXCEPT lozenges

·   Do not give to children under 2 years of age.

30

Benzoyl peroxide

In Schedule 2 to the current Poisons Standard

·   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.

31

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.

32

Bergamot oil

For the purpose of exclusion from the schedules to the current Poisons Standard; or when included in a schedule to the current Poisons Standard

·   Application to skin may increase sensitivity to sunlight.

33

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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

34

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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

35

Brompheniramine

(Entry 1 of 4)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

36

Brompheniramine

(Entry 2 of 4)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

37

Brompheniramine

(Entry 3 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

38

Brompheniramine

(Entry 4 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

39

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.

40

Cajuput oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·         in preparations or oils containing more than 25% of cajuput oil; and

·         packed in containers having:

- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

41

Camphor

(Entry 1 of 3)

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·         included as a natural component in essential oils containing greater than 2.5% of camphor but 10% or less of camphor; and

·         packed in containers having a nominal capacity of 25 mL 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.

42

Camphor

(Entry 2 of 3)

For the purpose of exclusion from the schedules to the current Poisons Standard when:

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

·         packed in containers having:

-  a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

-  a nominal capacity of 25 mL 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.

43

Camphor

(Entry 3 of 3)

When:

·  included in a schedule to the current Poisons Standard, and

·  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.

44

Cassia oil

When included in a schedule to the current Poisons Standard

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Avoid contact with skin.

·   DO NOT SWALLOW. [g]

45

Cetirizine

(Entry 1 of 2)

In preparations for oral use that are NOT specifically labelled for use only in children (between 1 year and 12 years of age)

·     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.

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

46

Cetirizine

(Entry 2 of 2)

In preparations for oral use specifically labelled for use only in children (between 1 year and 12 years of age)

·   This medication may cause drowsiness.

47

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.

48

Chloramphenicol

In medicines for ophthalmic use

·   Contact lens wearers should not use this product except on the advice of a doctor or optometrist.

·   If your eye infection does not improve within 48 hours, seek immediate medical advice.

·   Do not use in children under 2 years of age except on medical advice.

49

Chlorhexidine

(Entry 1 of 2)

In preparations for topical use on mucosal surfaces.

Note: If also for dermal use, Entry 2 below applies.

·   Avoid contact with eyes.

·   If in eyes, rinse well with water.

·   Chlorhexidine can cause severe allergic reactions.  Seek immediate medical assistance if this occurs.

50

Chlorhexidine

(Entry 2 of 2)

In preparations for dermal use

·   Avoid contact with eyes.

·   If in eyes, rinse well with water.

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

·   Chlorhexidine can cause severe allergic reactions. Seek immediate medical assistance if this occurs.

51

Chlorphenamine

(Entry 1 of 4)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

52

Chlorphenamine

(Entry 2 of 4)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

53

Chlorphenamine

(Entry 3 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

54

Chlorphenamine

(Entry 4 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

55

Choline salicylate

In preparations for topical oral use

·   Do not exceed the recommended dose.  Excessive or prolonged use can be harmful.

56

Cimetidine

In Schedule 3 to the current Poisons Standard

·   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 2 weeks, consult a doctor.

57

Cinchocaine

(Entry 1 of 2)

In preparations for rectal use only

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

58

Cinchocaine

(Entry 2 of 2)

In preparations 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.

59

Cineole

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·         in preparations or oils containing more than 25% of cineole (other than rosemary oil or camphor oil); and

·         packed in containers having:

-  a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

60

Cinnamon bark oil

When included in a schedule to the current Poisons Standard

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Avoid contact with skin.

·     DO NOT SWALLOW. [g]

61

Cinnamon leaf oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 25% of cinnamon leaf oil; and

·    packed in containers having:

- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

62

Citric acid and other fruit acids

(See also Alpha hydroxy acids)

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.

63

Clobetasone

In preparations for dermal use

·   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.

64

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.

65

Clove oil

(Entry 1 of 2)

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·  in preparations containing more than 25% of clove oil; and

·  packed in containers having:

-  a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

66

Clove oil

(Entry 2 of 2)

When included in a schedule to the current Poisons Standard

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Avoid contact with eyes.

·     DO NOT SWALLOW. [g]

67

Coal tar

In preparations for topical use

·   Avoid contact with eyes.

·   If skin irritation occurs, discontinue use.

·   Do not use for prolonged periods except on the advice of a doctor or pharmacist.

68

Datura spp

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

69

Desloratadine

In medicines for oral use

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

70

Dexchlorpheniramine

(Entry 1 of 4)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

71

Dexchlorpheniramine

(Entry 2 of 4)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

72

Dexchlorpheniramine

(Entry 3 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

73

Dexchlorpheniramine

(Entry 4 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

74

Dextromethorphan

(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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

75

Dextromethorphan

(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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

76

Dibromopropamidine

In medicines for ophthalmic use

·   Contact lens wearers should not use this product except on the advice of a doctor or optometrist.

·   If your eye infection does not improve within 48 hours, seek immediate medical advice.

77

Diclofenac

(Entry 1 of 3)

In preparations for oral use only in adults and children aged 12 years and over

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to diclofenac 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

78

Diclofenac

(Entry 2 of 3)

In preparations that include indications for oral use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to diclofenac 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing diclofenac, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

79

Diclofenac

(Entry 3 of 3)

When the preparation is for dermal use

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

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

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

80

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.

81

Dihydrocodeine

(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.

·    If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

82

Dihydrocodeine

(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.

·     If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

83

Diphenhydramine (Entry 1 of 5)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·    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.

·    and ( if 'x' < 12)

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

84

Diphenhydramine (Entry 2 of 5)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·    This medication may cause drowsiness.

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

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

85

Diphenhydramine (Entry 3 of 5)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·    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.

·   and (if ‘x’ < 12)

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

86

Diphenhydramine (Entry 4 of 5)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

87

Diphenhydramine (Entry 5 of 5)

In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2)

(Note: Diphenhydramine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Diphenhydramine (Entry 2 of 5))

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

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

·   If breastfeeding, consult a doctor or pharmacist before use.

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

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

88

Diphenoxylate

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.

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

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

89

Doxylamine

(Entry 1 of 5)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

90

Doxylamine

(Entry 2 of 5)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

91

Doxylamine

(Entry 3 of 5)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

92

Doxylamine

(Entry 4 of 5)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

93

Doxylamine

(Entry 5 of 5)

In oral medicines indicated for SHORT TERM USE IN INSOMNIA:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 2)

(Note: Doxylamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Doxylamine (Entry 2 of 5))

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

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

·   If breastfeeding, consult a doctor or pharmacist before use.

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

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

94

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.

95

Eletriptan

In divided oral preparations for relief of migraine

·   Do not use:

-    without a previous diagnosis of migraine by a doctor

-    if you have heart disease, peripheral vascular disease (a blood vessel disorder) or high blood pressure or have previously had a heart attack or stroke.

·   Consult your doctor or pharmacist before use:

-    if you think you may be at risk of heart disease (including if you are post-menopausal or a male over the age of 40)

-    if you have liver or kidney problems or any other medical conditions

-    if you are taking any other medicines, including for migraine, depression or anxiety

-    if you are pregnant or breastfeeding.

·   Speak to a doctor or pharmacist if your migraine attacks become more frequent. Overuse of this medicine may worsen your condition.

·   This medicine may cause drowsiness. If affected, do not drive a vehicle or operate machinery.

96

Esomeprazole

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 2 weeks of completing the course, consult a doctor.

·   Ask your doctor or pharmacist before use if you are taking other medicines regularly.

97

Eucalyptus oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 25% of eucalyptus oil; and

·    packed in containers having:

-    a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

98

Eugenol

(Entry 1 of 2)

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 25% of eugenol; and

·    packed in containers having:

-  a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

99

Eugenol

(Entry 2 of 2)

When included in a schedule to the current Poisons Standard

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Avoid contact with eyes.

·     DO NOT SWALLOW. [g]

100

Famciclovir

In medicines for oral use

·   If you are taking other medicines regularly, consult your pharmacist or doctor before use.

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

·   Do not take [this product/insert name of product] if you are allergic to famciclovir or penciclovir.

·   Do not take [this product/insert name of product] if you have problems with your immune system.

·   Do not take [this product/insert name of product] if you have kidney problems, unless advised by a doctor.

·   If you have high blood pressure, heart problems, liver problems, diabetes or other medical conditions, consult your pharmacist or doctor before use.

·   If you have symptoms and signs of an infection other than your cold sore, consult your pharmacist or doctor before use.

101

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 2 weeks, consult a doctor.

102

Fennel oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations or oils containing more than 5% of methyl chavicol; and

·    packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.

103

Fexofenadine

In medicines for oral use

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

104

Fluconazole

In oral medicines for treatment of vaginal candidiasis

·   Seek medical advice before first course of treatment.

·   Do not use if pregnant or [trying/likely] to become pregnant.

·   See a doctor before use if you are diabetic.

·   Ask your doctor or pharmacist before use if you are taking warfarin.

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

·   See a doctor if problem returns.

105

Fluorides

(Entry 1 of 3)

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in dental hygiene products (other than pastes, powders or gels for the cleaning of teeth) containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg 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.

106

Fluorides

(Entry 2 of 3)

When included in a schedule to the current Poisons Standard except oral fluoride supplements

·   Do not swallow.

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

107

Fluorides

(Entry 3 of 3)

In Schedule 2 to the current Poisons Standard in oral preparations as fluoride supplements

·   Do not use if pregnant.

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

·   Do not use except on the advice of a dentist.

108

Flurbiprofen

(Entry 1 of 2)

In oral preparations that do NOT include indications for use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to flurbiprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

109

Flurbiprofen

(Entry 2 of 2)

In oral preparations that include indications for use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to flurbiprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing flurbiprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

110

Folic acid

In preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects

·   Do not exceed the stated dose except on medical advice.

·   If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice.

111

Glycollic acid

(See Alpha hydroxy acids)

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.

112

Guaifenesin

(Guaiphenesin)

(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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

113

Guaifenesin (Guaiphenesin)

(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.

·  If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

114

Hexachlorophane

In preparations for skin cleansing purposes containing 3% or less of hexachlorophane.

·   For external washing only.

·   Rinse skin thoroughly after use.

115

Hydrocortisone

(Entry 1 of 2)

In preparations for dermal use

·   either

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

or (if Schedule 2 or 3 to the current Poisons Standard excludes use in children under 12 years of age)

-          Do not use for children under 12 years of age.

·   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.

116

Hydrocortisone

(Entry 2 of 2)

In preparations for topical rectal use

·   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.

117

Hydrogen peroxide

(Entry 1 of 3)

In concentrations of more than 3% up to 10%

·     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]

118

Hydrogen peroxide

(Entry 2 of 3)

In concentrations of more than 10% up to 20%

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Irritant

Attacks eyes - protect eyes when using.

119

Hydrogen peroxide

(Entry 3 of 3)

In concentrations of more than 20%

·     either

-            READ SAFETY DIRECTIONS. [f]

or

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

·   SAFETY DIRECTIONS

Corrosive

Attacks eyes - protect eyes when using

Avoid contact with skin.

120

Hydroquinone

In Schedule 2 to the current Poisons Standard

·   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 3 months, seek doctor’s advice.

·   Do not exceed recommended dose.  Excessive or prolonged use should be avoided because darkening of the skin can occur.

121

Hydroxyanthracene derivatives such as those from:

·       Aloe

·       Buckthorn

·       Cascara

·       Frangula

·       Rhubarb

·       Senna

(Entry 1 of 3)

Where the MRDD contains MORE than 10 mg and the product IS promoted or marketed as a laxative

·   Not recommended for use by children under 12 years of age.

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

·   Drink plenty of water.

·   Prolonged use may cause serious bowel problems.

·   Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea.

·   If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product.

122

Hydroxyanthracene derivatives such as those from:

·       Aloe

·       Buckthorn

·       Cascara

·       Frangula

·       Rhubarb

·       Senna

(Entry 2 of 3)

Where the MRDD contains MORE than 10 mg and the product IS NOT promoted or marketed as a laxative

·   Not recommended for use by children under 12 years of age.

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

·   This product may have a laxative effect.

·   Prolonged use may cause serious bowel problems.

·   Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea.

·   If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product.

·   This product contains [insert name of the herb(s) or the chemical component(s)].

123

Hydroxyanthracene derivatives such as those from:

·       Aloe

·       Buckthorn

·       Cascara

·       Frangula

·       Rhubarb

·       Senna

(Entry 3 of 3)

Where the MRDD contains 10 mg OR LESS and the product IS promoted or marketed as laxative

·   Not recommended for use by children under 12 years of age.

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

·   Drink plenty of water.

·   Prolonged use may cause serious bowel problems.

124

8-Hydroxyquinoline (including salts and derivatives)

In preparations for internal use

·   Do not take for periods longer than 4 weeks except on medical advice.

125

Hyoscine

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

126

Hyoscyamine

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

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

127

Hyoscyamus niger

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

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

128

Ibuprofen

(Entry 1 of 6)

For the purpose of exclusion from the schedules to the current Poisons Standard, when the preparation is for oral use in adults and children aged 12 years and over.

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ibuprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Unless a doctor has told you to, do not use if you are aged 65 years or over.

129

Ibuprofen

(Entry 2 of 6)

When included in a schedule to the current Poisons Standard for oral use in adults and children aged 12 years and over

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ibuprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

130

Ibuprofen

(Entry 3 of 6)

For the purpose of exclusion from the schedules to the current Poisons Standard, for oral use in children under 12 years of age

·       Do not use if you have a stomach ulcer.

·       Do not use if you have impaired kidney function.

·       Do not use if you have heart failure.

·       Do not use if you are allergic to ibuprofen 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 if you have asthma.

·       Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·       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 and increase the risk of heart attack, stroke or liver damage.

·       Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·       Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

·       Unless a doctor has told you to, do not use if you are aged 65 years or over.

·       Do not use in children 6 years of age or less.

131

Ibuprofen

(Entry 4 of 6)

When included in a schedule to the current Poisons Standard for oral use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ibuprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

132

Ibuprofen

(Entry 5 of 6)

In combination with paracetamol, in medicines for oral use

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

·   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.

·   Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

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

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ibuprofen 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 if you have asthma.

·   Unless a doctor has told you to, do not use if you are aged 65 years or over.

·   Do not take with other products containing paracetamol, ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly, unless advised to do so by a doctor or pharmacist.

·   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.

133

Ibuprofen

(Entry 6 of 6)

In preparations for dermal use

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

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

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

134

Indomethacin

In preparations for external use

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

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

·   Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly.

135

Iodine

(Entry 1 of 2)

In preparations for dermal use

·   If skin irritation or rash occurs, discontinue use immediately.

136

Iodine

(Entry 2 of 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.

137

Ipecacuanha

(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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

138

Ipecacuanha

(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.

-      If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

139

Ipratropium bromide

In metered aerosols

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

140

Ketoprofen

(Entry 1 of 3)

In preparations for oral use in adults and children aged 12 years and over

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ketoprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice. Do not use at all during the last 3 months of pregnancy.

141

Ketoprofen

(Entry 2 of 3)

In preparations for oral use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ketoprofen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with products containing ketoprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

142

Ketoprofen

(Entry 3 of 3)

In preparations for dermal use

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

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

·   Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly.

143

Lactic acid

(See Alpha hydroxy acids)

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.

144

Lansoprazole

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 2 weeks of completing the course, consult a doctor.

·   Ask your doctor or pharmacist before use if you are taking other medicines regularly.

145

Lemon oil

For the purpose of exclusion from the schedules to the current Poisons Standard

·   Application to skin may increase sensitivity to sunlight.

146

Leptospermum scoparium oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 25% of Leptospermum scoparium oil; and

·    packed in containers having:

- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

147

Levocabastine

(Entry 1 of 2)

In eye or nasal preparations containing 0.5 mg/mL or less of levocabastine

·   Do not use if pregnant.

148

Levocabastine

(Entry 2 of 2)

In eye or nasal preparations containing MORE THAN 0.5 mg per mL 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.

149

Levocetirizine

(Entry 1 of 2)

In preparations for oral use labelled for use in adults

·     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.

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

150

Levocetirizine

(Entry 2 of 2)

In preparations for oral use specifically labelled for use only in children (between 1 year and 12 years of age)

·   This medication may cause drowsiness.

151

Lidocaine (Lignocaine)

(Entry 1 of 4)

In dermal preparations containing MORE THAN 2% 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.

152

Lidocaine (Lignocaine)

(Entry 2 of 4)

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

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

153

Lidocaine (Lignocaine)

(Entry 3 of 4)

In preparations for topical oral use containing more than 1.5% lidocaine.

·   Do not use for teething pain in children.

154

Lidocaine (Lignocaine)

(Entry 4 of 4)

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.

155

Lime oil

For the purpose of exclusion from the schedules to the current Poisons Standard

·   Application to skin may increase sensitivity to sunlight.

156

Lindane

In preparations for external use

·   Do not use on broken skin.

·   Ask your doctor or pharmacist before use.

·   This preparation should be used with caution on infants, small children and pregnant or breastfeeding women.

157

Loperamide hydrochloride

In medicines for oral use

·   If the condition persists after 2 days of treatment, seek medical advice as soon as possible.

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

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

·   Drink plenty of fluids as fluid and electrolyte depletion may occur with diarrhoea.  If dehydration is suspected seek medical attention.

·   Do not take if you have a medical condition where constipation should be avoided.

·   See your doctor or pharmacist before taking [this product/insert name of product] if you have a fever, severe stomach pain, bloody diarrhoea or ongoing condition affecting the bowel.

158

Loratadine

In medicines for oral use

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

159

Marjoram oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 50% of marjoram oil; and

·    packed in containers having a nominal capacity of 50 mL or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.

160

Mefenamic acid

When indicated exclusively for the treatment of dysmenorrhoea

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to mefenamic acid 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing mefenamic acid, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

161

Melaleuca oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 25% of melaleuca oil; and

·    when packed in containers having:

- a nominal capacity of 15 mL or less, fitted with a restricted flow insert; or

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

162

Melatonin

In modified-release tablets containing 2 mg or less of melatonin

·   Do not use if:

-   you are under 55 years of age

-   you are taking any other medicines for sleep

-   you have liver problems

-   you are pregnant or breastfeeding.

·   Unless a doctor has told you to, do not use:

-   for more than 3 weeks

-   if you have kidney problems

-   if you have an autoimmune disease.

·   Consult a pharmacist or doctor before use if you are taking other medicines regularly.

·   Do not drink alcohol while taking this medicine.

·   This medication may cause drowsiness.  If affected do not drive or operate machinery.

163

Menthol

(Entry 1 of 5)

In dermal preparations containing 1% or less, EXCEPT patches

·   Avoid contact with eyes.

164

Menthol

(Entry 2 of 5)

In dermal preparations containing more than 1% and up to 5%, EXCEPT patches

·   Avoid contact with eyes.

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

·   If irritation develops, discontinue use.

165

Menthol

(Entry 3 of 5)

In dermal preparations containing more than 5%, EXCEPT patches

·   Avoid contact with eyes.

·   Contains a high concentration of menthol, which can cause severe skin irritation.

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

·   If irritation develops, discontinue use.

166

Menthol

(Entry 4 of 5)

In dermal patches containing more than 1% and up to 5%

·   If irritation develops, discontinue use.

167

Menthol

(Entry 5 of 5)

In dermal patches containing more than 5%

·   Contains a high concentration of menthol, which can cause severe skin irritation.

·   If irritation develops, discontinue use.

168

Methyl salicylate

(Entry 1 of 2)

In dermal preparations containing 1% or less of methyl salicylate

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

·   Do not use in children 6 years of age or less.

·   Application to skin may increase sensitivity to sunlight.

·   Avoid prolonged exposure in the sun.

169

Methyl salicylate

(Entry 2 of 2)

In dermal preparations containing more than 1% of methyl salicylate

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

·   Do not use in children 6 years of age or less.

·   Application to skin may increase sensitivity to sunlight.

·   Avoid prolonged exposure in the sun.

·   If irritation develops, discontinue use.

170

Metoclopramide

In medicines for oral use

·   Do not use in children and adolescents aged under 18 years.

·   Tell your doctor or pharmacist before use if you are taking other medicines.

·   Do not use if you have epilepsy [(seizures)/(fits)].

171

Methoxamine

In nasal decongestant preparations for topical use

·   If congestion persists consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

172

Miconazole

(Entry 1 of 2)

In preparations for vaginal use

·   Seek medical advice before first course of treatment.

·   See a doctor before use if you are pregnant or diabetic.

·   Ask your doctor or pharmacist before use if you are taking warfarin.

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

·   See a doctor if problem returns.

173

Miconazole

(Entry 2 of 2)

In preparations for topical oral use

·   Ask your doctor or pharmacist before use if you are taking warfarin.

174

Mometasone

(Entry 1 of 2)

In preparations for dermal use

·    Do not use:

-   in or around the eyes

-   for acne

-   on broken skin or skin infections (e.g. cold sores, shingles, thrush, tinea)

-   if you are sensitive to any corticosteroids.

·    Unless a doctor has told you to, do not use:

-   on the face, large areas of the skin, or areas that rub together

-   under a bandage, dressing, nappies or plastic pants

-   for more than 7 days

-   if you are pregnant or breastfeeding

-   for children under 12 years old.

·    If irritation occurs, discontinue use and seek medical advice.

·    Seek medical advice if there is no improvement in symptoms after using for 1 week.

175

Mometasone

(Entry 2 of 2)

In nasal spray preparations

·    Do not exceed the maximum stated dose.

·    Do not use for more than 6 months without the advice of your doctor or pharmacist.

·    See your doctor or pharmacist before using this product if:

-   you have a nasal or sinus infection

-   you have recently had an injury or surgery to your nose

-   you have ulceration in your nose

-   you are pregnant or breastfeeding.

·    See your doctor or pharmacist if:

-   symptoms are not relieved within 7 days

-   your nose bleeds

-   you develop signs or symptoms of a nasal or sinus infection such as fever, pain or swelling, or discoloured nasal discharge

-   you have eye pain or visual disturbances.

176

Naphazoline

(Entry 1 of 2)

In nasal decongestant preparations for topical use

·   If congestion persists consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

177

Naphazoline

(Entry 2 of 2)

In topical eye preparations

·   Prolonged use may be harmful.

·   Consult a doctor or pharmacist if using other eye products.

·   Do not use if you have glaucoma or other serious eye conditions.

·   If symptoms persist, consult a doctor or pharmacist.

178

Naproxen

(Entry 1 of 2)

In preparations for oral use in adults and children aged 12 years and over

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to naproxen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

179

Naproxen

(Entry 2 of 2)

When the preparation includes indications for oral use in children under 12 years of age

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to naproxen 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 if you have asthma.

·   Unless advised by your doctor or pharmacist, do not use with other products containing naproxen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.

·   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 and increase the risk of heart attack, stroke or liver damage.

·   Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.

·   Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.

180

Nasal decongestant preparations, including:

·  Methoxamine

·  Naphazoline

·  Oxymetazoline

·  Phenylephrine

·  Tetrahydrozoline

·  Tramazoline

·  Tymazoline

·  Xylometazoline

When in nasal decongestant preparations for topical use

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

181

Nizatidine

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 2 weeks, consult a doctor.

182

Nutmeg oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 50% of nutmeg oil; and

·    packed in containers having a nominal capacity of 25 mL or less, fitted with a restricted flow insert

·   KEEP OUT OF REACH OF CHILDREN.

183

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.

184

Omeprazole

In preparations 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 2 weeks of completing the course, consult a doctor.

·   Ask your doctor or pharmacist before use if you are taking other medicines regularly.

185

Orange oil (bitter)

For the purpose of exclusion from the schedules to the current Poisons Standard

·   Application to skin may increase sensitivity to sunlight.

186

Oxymetazoline

(Entry 1 of 4)

In nasal decongestant preparations for topical use

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

187

Oxymetazoline

(Entry 2 of 4)

(See also vasoconstrictor eye drops)

In topical eye preparations

·   Prolonged use may be harmful.

·   Consult a doctor or pharmacist if using other eye products.

·   Do not use if you have glaucoma or other serious eye conditions.

·   If symptoms persist, consult a doctor or pharmacist.

188

Oxymetazoline

(Entry 3 of 4)

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

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

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

189

Oxymetazoline

(Entry 4 of 4)

In nasal decongestant preparations for topical use 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)

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

·   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.

190

Pantoprazole

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 2 weeks of completing the course, consult a doctor.

·   Ask your doctor or pharmacist before use if you are taking other medicines regularly.

191

Paracetamol

(Entry 1 of 3)

For the purpose of exclusion from the schedules to the current Poisons Standard

·   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.

192

Paracetamol

(Entry 2 of 3)

In Schedule 2 or 3 to the current Poisons Standard

·     either or both

-        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.

193

Paracetamol

(Entry 3 of 3)

In combination with ibuprofen, in medicines for oral use

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

·   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.

·   Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

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

·   Do not use if you have a stomach ulcer.

·   Do not use if you have impaired kidney function.

·   Do not use if you have heart failure.

·   Do not use if you are allergic to ibuprofen 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 if you have asthma.

·   Unless a doctor has told you to, do not use if you are aged 65 years or over.

·   Do not take with other products containing paracetamol, ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly, unless advised to do so by a doctor or pharmacist.

·     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.

194

Pennyroyal oil

For the purpose of exclusion from the schedules to the current Poisons Standard when:

·    in preparations containing more than 4% of d-pulegone; and

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

·   KEEP OUT OF REACH OF CHILDREN.

·   NOT TO BE TAKEN.

195

Pentoxyverine

(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.

·   If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

196

Pentoxyverine

(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.

·       If [coughing/symptoms] persist(s), consult your doctor or pharmacist.

197

Permanganates

(see also Potassium permanganate)

When included in Schedule 6 to the current Poisons Standard

·     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.

198

Pheniramine

(Entry 1 of 4)

In oral medicines that include dosage instructions for adults and children aged from 'x' years (where 'x' must not be less than 2)

when NOT separately specified in this table

·       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.

·       and ( if 'x' < 12)

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

199

Pheniramine

(Entry 2 of 4)

In oral medicines that ONLY include dosage instructions for CHILDREN aged between 'x' and ‘y’ years (where 'x' must not be less than 2, and ‘y’ must not be more than 11)

when NOT separately specified in this table

·        This medication may cause drowsiness.

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

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

200

Pheniramine

(Entry 3 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which include dosage instructions for adults and children aged from ‘x’ years (where ‘x’ must not be less than 6)

·     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.

·   and (if ‘x’ < 12)

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

201

Pheniramine

(Entry 4 of 4)

In oral preparations indicated for COUGH, COLD OR FLU:

·  which ONLY include dosage instructions for CHILDREN aged between ‘x’ and ‘y’ years (where ‘x’ must not be less than 6 and ‘y’ must not be more than 11)

·   This medication may cause drowsiness.

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

·   and (if ‘x’ < 12)

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

202

Phenol and any other homologue of phenol

When included in Schedule 2 to the current Poisons Standard

·     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]

203

Phenylephrine

(Entry 1 of 7)

In nasal decongestant preparations for topical use

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

204

Phenylephrine

(Entry 2 of 7)

(See also vasoconstrictor eye drops)

In topical eye preparations

·   Prolonged use may be harmful.

·   Consult a doctor or pharmacist if using other eye products.

·   Do not use if you have glaucoma or other serious eye conditions.

·   If symptoms persist, consult a doctor or pharmacist.

205

Phenylephrine

(Entry 3 of 7)

In oral preparations that are NOT indicated for cough, cold or flu

·   See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication.

·   This product may cause sleeplessness.

206

Phenylephrine

(Entry 4 of 7)

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

·   See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication.

·   This product may cause sleeplessness.

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

207

Phenylephrine

(Entry 5 of 7)

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

·   See your doctor or pharmacist before taking [this product/insert name of product] if you have high blood pressure or heart problems or are taking antidepressant medication.

·   This product may cause sleeplessness.

·   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.

208

Phenylephrine

Entry 6 of 7)

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

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

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

209

Phenylephrine

(Entry 7 of 7)

In nasal decongestant preparations for topical use 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)

·   If congestion persists, consult your doctor or pharmacist.

·   Do not use for more than 3 days at a time unless advised by a doctor or pharmacist.

·   Frequent or prolonged use may cause nasal congestion to recur or worsen.

·   either (if ‘x’ is 11)

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

    or (if ‘x’ is 6, 7, 8, 9 or 10)