Therapeutic Goods (Medicines Advisory Statements) Specification 2021
I, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.
Dated 22 December 2021
Dr Jane Cook
First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Interpretation
6 Application
7 Medicines advisory statements
8 Transitional arrangements
9 Repeals
Schedule 1—Required Advisory Statements for Medicine Labels No. 6
This instrument is the Therapeutic Goods (Medicines Advisory Statements) Specification 2021.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | 1 January 2022. | 1 January 2022 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under subsection 3(5A) of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) current Poisons Standard;
(b) label;
(c) medicine;
(d) supply;
(e) therapeutic use.
In this instrument:
Act means the Therapeutic Goods Act 1989.
dermal use means application to the skin primarily for localised effect.
divided preparation means a preparation manufactured and packed as discrete pre-measured dosage units prior to supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
dosage unit means an individual dose of a medicine for therapeutic use, and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
essential oils means:
(a) products obtained from natural raw materials by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation; or
(b) oils of equivalent composition to products mentioned in paragraph (a) that are derived through synthetic means; or
(c) prepared mixtures of oils of equivalent composition to products mentioned in paragraph (a) that comprise a mixture of synthetic and natural components.
external, in relation to the use of a medicine, means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
internal use means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect:
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
main label means:
(a) where there are two or more labels or two or more portions of a single label—that label or portion of the label where the product name is more or most conspicuously shown; or
(b) where the product name is equally conspicuous on two or more labels or portions of a label—each such label or portion.
medicine in a prescribed class means medicine included in a class of medicine prescribed by the Regulations for the purposes of paragraph 3(5)(ca) of the Act.
MRDD or maximum recommended daily dose means the maximum approved dose per day for a medicine used for its main indication in adults.
Regulations means the Therapeutic Goods Regulations 1990.
signal words, in relation to a substance included in a schedule to the current Poisons Standard, means the signal word or words as specified in subsection 5(4).
topical use means application of a substance for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
References to substances
(1) In this instrument, unless the contrary intention appears, a reference to a substance includes the following:
(a) that substance prepared from natural sources or artificially;
(b) if the substance is a plant (other than a plant included in Schedule 8 or 9 to the current Poisons Standard)—that plant or any part of that plant when packed or prepared for therapeutic use;
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative;
(d) every alkaloid of the substance and every salt of such an alkaloid;
(e) every stereoisomer of the substance and every salt of such a stereoisomer, other than where the stereoisomer is defined in the substance name (for example, dextromethorphan);
(f) a preparation or admixture containing any proportion of the substance;
but does not include:
(g) a preparation or product included in Appendix A of the current Poisons Standard; or
(h) a substance included in Appendix G of the current Poisons Standard at a concentration not exceeding the concentration specified in that Appendix in relation to the substance; or
(i) any other substance included in Schedules 1 to 6 to the current Poisons Standard, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8 to the current Poisons Standard.
References to concentration, strength or quantity of substances
(2) In this instrument, unless the contrary intention appears, for a reference to a concentration, strength or quantity of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance; and
(b) the expression “1%” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 mL of the preparation; or
(ii) in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning.
References to symbols
(3) A reference in column 4 of the table in Schedule 1, to a symbol in column 2 of an item in the following table, has the meaning set out in column 3 of that item.
Column 1 | Column 2 | Column 3 |
Item | Symbol | Meaning |
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 |
Signal words
(4) The signal word or words for a substance included in a schedule to the current Poisons Standard mentioned in column 2 of an item in the following table, that is to be used for the purpose in column 3 of that item, are specified in column 4 of that item.
Signal word or words for substances | |||
Column 1 | Column 2 | Column 3 | Column 4 |
Item | Schedule to the current Poisons Standard | Purpose | Signal word or words |
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 |
This instrument applies to a medicine that is a medicine in a prescribed class.
7 Medicines advisory statements
(1) Subject to subsection (2), the advisory statements mentioned in column 4 of an item in the table in Schedule 1, are specified in relation to a medicine in a prescribed class that contains the substance described in column 2 of that item, in the circumstances set out in column 3 of that item, for the purposes of paragraph 3(5)(ca) of the Act.
Alternative statements
(2) The following advisory statements are specified in relation to a medicine in a prescribed class for the purposes of paragraph 3(5)(ca) of the Act, as an alternative to the advisory statements specified in relation to the medicine by subsection (1):
(a) the advisory statements specified by subsection (1) in relation to the medicine, as varied in a manner that does not change the intent of the advisory statements;
(b) if more than one advisory statement is specified by subsection (1) in relation to the medicine—the advisory statements combined to form a simple sentence in a manner that does not change the intent of each advisory statement.
Note: Unless otherwise specified in column 3 of the table in Schedule 1, the requirements only apply if the substance is included in the medicine as an active ingredient.
(1) In this section:
former specification means the Therapeutic Goods (Medicines Advisory Statements) Specification 2019, as in force immediately before the commencement of this instrument.
transition period means the period beginning on the commencement of this instrument and ending on 30 June 2023.
(2) Despite the repeal of the former specification by this instrument, the former specification continues to apply for the duration of the transition period such that the advisory statements specified in the former specification may continue to be used on a label of a medicine in a prescribed class for the purposes of paragraph 3(5)(ca) of the Act, as an alternative to the advisory statements specified under section 7.
Note: During the transition period, the label of a medicine may contain the applicable advisory statements specified by the former specification instead of the advisory statements specified by this instrument in relation to the medicine. However, once the transition period ceases, the label must contain the advisory statements specified by this instrument in relation to the medicine.
The Therapeutic Goods (Medicines Advisory Statements) Specification 2019 is repealed.
Schedule 1—Required Advisory Statements for Medicine Labels No. 6
Note: See section 7.
Required Advisory Statements for Medicine Labels | |||
Column 1 | Column 2 | Column 3 | Column 4 |
Item | Substances | Circumstances | Required Statements |
1 | Alclometasone | When included in 3 to the current Poisons Standard |
|
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 |
- 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 between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
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) |
|
4 | Alpha hydroxy acids, including:
| When used as active ingredients in preparations for topical use |
|
5 | Amethocaine (tetracaine) (Entry 1 of 2) | When included in Schedule 2 to the current Poisons Standard and for dermal use |
|
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 |
|
7 | Ammonia and ammonium salts, including
(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 |
|
8 | Ammonia and ammonium salts, including
(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 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.
|
9 | Anise oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
10 | Antihistamines (Entry 1 of 5) including:
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 |
- 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 between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
11 | Antihistamines (Entry 2 of 5) including:
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 |
|
12 | Antihistamines (Entry 3 of 5) including:
when NOT separately specified in this table | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
13 | Antihistamines (Entry 4 of 5) including:
when NOT separately specified in this table | In oral preparations indicated for COUGH, COLD OR FLU:
|
- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
14 | Antihistamines (Entry 5 of 5) including:
| In oral medicines indicated for SHORT TERM USE IN INSOMNIA:
(Note: Antihistamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Antihistamines (Entry 2 of 5)) |
|
15 | Aspartame | When for oral ingestion and included in medicines as an active or excipient ingredient |
|
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 |
|
17 | Aspirin (Entry 2 of 3) | When the preparation IS indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation |
|
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) |
|
19 | Atropa belladona | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
20 | Atropine | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
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 |
|
22 | Azadirachta indica including its extracts and derivatives (Entry 2 of 2) | When included in Schedule 6 to the current Poisons Standard |
|
23 | Azelastine | In preparations for topical ophthalmic or nasal administration |
|
24 | Basil oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
25 | Bay oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
26 | Benzocaine (Entry 1 of 4) | In dermal preparations containing MORE than 2% of total local anaesthetic substances |
|
27 | Benzocaine (Entry 2 of 4) | In dermal preparations containing 2% OR LESS of total local anaesthetic substances |
|
28 | Benzocaine (Entry 3 of 4) | In lozenges |
|
29 | Benzocaine (Entry 4 of 4) | In preparations for topical oral use EXCEPT lozenges |
|
30 | Benzoyl peroxide | In Schedule 2 to the current Poisons Standard |
|
31 | Benzydamine | In preparations for topical use or dermal use |
|
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 |
|
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 |
|
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 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.
|
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 |
- 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 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 |
|
37 | Brompheniramine (Entry 3 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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 |
|
40 | Cajuput oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
41 | Camphor (Entry 1 of 3) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
42 | Camphor (Entry 2 of 3) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
43 | Camphor (Entry 3 of 3) | When:
|
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
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 |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with skin.
|
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) |
- 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.
|
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) |
|
47 | Chelidonium majus | When the preparation is for oral use |
|
48 | Chloramphenicol | In medicines for ophthalmic use |
|
49 | Chlorhexidine (Entry 1 of 2) | In preparations for topical use on mucosal surfaces.
Note: If also for dermal use, Entry 2 below applies. |
|
50 | Chlorhexidine (Entry 2 of 2) | In preparations for dermal use |
|
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 |
- 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 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 |
|
53 | Chlorphenamine (Entry 3 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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 |
|
56 | Cimetidine | In Schedule 3 to the current Poisons Standard |
|
57 | Cinchocaine (Entry 1 of 2) | In preparations for rectal use only |
|
58 | Cinchocaine (Entry 2 of 2) | In preparations for dermal use |
|
59 | Cineole | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
60 | Cinnamon bark oil | When included in a schedule to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with skin.
|
61 | Cinnamon leaf oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
62 | Citric acid and other fruit acids (See also Alpha hydroxy acids) | When used as active ingredients in preparations for topical use |
|
63 | Clobetasone | In preparations for dermal use |
|
64 | Clotrimazole | In preparations for vaginal use |
|
65 | Clove oil (Entry 1 of 2) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
66 | Clove oil (Entry 2 of 2) | When included in a schedule to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with eyes.
|
67 | Coal tar | In preparations for topical use |
|
68 | Datura spp | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
69 | Desloratadine | In medicines for oral use |
|
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 |
- 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 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 |
|
72 | Dexchlorpheniramine (Entry 3 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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 |
|
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 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.
|
76 | Dibromopropamidine | In medicines for ophthalmic use |
|
77 | Diclofenac (Entry 1 of 3) | In preparations for oral use only in adults and children aged 12 years and over |
|
78 | Diclofenac (Entry 2 of 3) | In preparations that include indications for oral use in children under 12 years of age |
|
79 | Diclofenac (Entry 3 of 3) | When the preparation is for dermal use |
|
80 | Diethyltoluamide (DEET) | All, including where present as an excipient |
|
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 |
|
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 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.
|
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 |
- 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 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 |
|
85 | Diphenhydramine (Entry 3 of 5) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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:
(Note: Diphenhydramine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Diphenhydramine (Entry 2 of 5)) |
|
88 | Diphenoxylate | In medicines for oral use |
- 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.
|
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 |
- 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 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 |
|
91 | Doxylamine (Entry 3 of 5) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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:
(Note: Doxylamine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Doxylamine (Entry 2 of 5)) |
|
94 | Econazole | In preparations for vaginal use |
|
95 | Eletriptan | In divided oral preparations for relief of migraine |
- 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.
- 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.
|
96 | Esomeprazole | In medicines for oral use |
|
97 | Eucalyptus oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
98 | Eugenol (Entry 1 of 2) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
99 | Eugenol (Entry 2 of 2) | When included in a schedule to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with eyes.
|
100 | Famciclovir | In medicines for oral use |
|
101 | Famotidine | In medicines for oral use |
|
102 | Fennel oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
103 | Fexofenadine | In medicines for oral use |
|
104 | Fluconazole | In oral medicines for treatment of vaginal candidiasis |
|
105 | Fluorides (Entry 1 of 3) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
106 | Fluorides (Entry 2 of 3) | When included in a schedule to the current Poisons Standard except oral fluoride supplements |
|
107 | Fluorides (Entry 3 of 3) | In Schedule 2 to the current Poisons Standard in oral preparations as fluoride supplements |
|
108 | Flurbiprofen (Entry 1 of 2) | In oral preparations that do NOT include indications for use in children under 12 years of age |
|
109 | Flurbiprofen (Entry 2 of 2) | In oral preparations that include indications for use in children under 12 years of age |
|
110 | Folic acid | In preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects |
|
111 | Glycollic acid (See Alpha hydroxy acids) | When used as active ingredients in preparations for topical use |
|
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 |
|
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 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.
|
114 | Hexachlorophane | In preparations for skin cleansing purposes containing 3% or less of hexachlorophane. |
|
115 | Hydrocortisone (Entry 1 of 2) | In preparations for dermal use |
- 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.
|
116 | Hydrocortisone (Entry 2 of 2) | In preparations for topical rectal use |
|
117 | Hydrogen peroxide (Entry 1 of 3) | In concentrations of more than 3% up to 10% |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Irritant Avoid contact with eyes.
|
118 | Hydrogen peroxide (Entry 2 of 3) | In concentrations of more than 10% up to 20% |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Irritant Attacks eyes - protect eyes when using. |
119 | Hydrogen peroxide (Entry 3 of 3) | In concentrations of more than 20% |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Corrosive Attacks eyes - protect eyes when using Avoid contact with skin. |
120 | Hydroquinone | In Schedule 2 to the current Poisons Standard |
|
121 | Hydroxyanthracene derivatives such as those from:
(Entry 1 of 3) | Where the MRDD contains MORE than 10 mg and the product IS promoted or marketed as a laxative |
|
122 | Hydroxyanthracene derivatives such as those from:
(Entry 2 of 3) | Where the MRDD contains MORE than 10 mg and the product IS NOT promoted or marketed as a laxative |
|
123 | Hydroxyanthracene derivatives such as those from:
(Entry 3 of 3) | Where the MRDD contains 10 mg OR LESS and the product IS promoted or marketed as laxative |
|
124 | 8-Hydroxyquinoline (including salts and derivatives) | In preparations for internal use |
|
125 | Hyoscine | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
126 | Hyoscyamine | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
127 | Hyoscyamus niger | In preparations for oral use, EXCEPT where indicated exclusively for the treatment of motion/travel sickness |
|
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. |
|
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 |
|
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 |
|
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 |
|
132 | Ibuprofen (Entry 5 of 6) | In combination with paracetamol, in medicines for oral use |
|
133 | Ibuprofen (Entry 6 of 6) | In preparations for dermal use |
|
134 | Indomethacin | In preparations for external use |
|
135 | Iodine (Entry 1 of 2) | In preparations for dermal use |
|
136 | Iodine (Entry 2 of 2) | In preparations for internal use containing 300 micrograms or more of iodine per recommended daily dose |
|
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 |
|
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 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 |
|
140 | Ketoprofen (Entry 1 of 3) | In preparations for oral use in adults and children aged 12 years and over |
|
141 | Ketoprofen (Entry 2 of 3) | In preparations for oral use in children under 12 years of age |
|
142 | Ketoprofen (Entry 3 of 3) | In preparations for dermal use |
|
143 | Lactic acid (See Alpha hydroxy acids) | When used as active ingredients in preparations for topical use |
|
144 | Lansoprazole | In medicines for oral use |
|
145 | Lemon oil | For the purpose of exclusion from the schedules to the current Poisons Standard |
|
146 | Leptospermum scoparium oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
147 | Levocabastine (Entry 1 of 2) | In eye or nasal preparations containing 0.5 mg/mL or less of levocabastine |
|
148 | Levocabastine (Entry 2 of 2) | In eye or nasal preparations containing MORE THAN 0.5 mg per mL of levocabastine. |
- 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 |
- 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.
|
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) |
|
151 | Lidocaine (Lignocaine) (Entry 1 of 4) | In dermal preparations containing MORE THAN 2% of total local anaesthetic substances |
|
152 | Lidocaine (Lignocaine) (Entry 2 of 4) | In dermal preparations containing 2% OR LESS of total local anaesthetic substances |
|
153 | Lidocaine (Lignocaine) (Entry 3 of 4) | In preparations for topical oral use containing more than 1.5% lidocaine. |
|
154 | Lidocaine (Lignocaine) (Entry 4 of 4) | In lozenges |
|
155 | Lime oil | For the purpose of exclusion from the schedules to the current Poisons Standard |
|
156 | Lindane | In preparations for external use |
|
157 | Loperamide hydrochloride | In medicines for oral use |
|
158 | Loratadine | In medicines for oral use |
|
159 | Marjoram oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
160 | Mefenamic acid | When indicated exclusively for the treatment of dysmenorrhoea |
|
161 | Melaleuca oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
- 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 |
|
162 | Melatonin | In modified-release tablets containing 2 mg or less of melatonin |
- you are under 55 years of age - you are taking any other medicines for sleep - you have liver problems - you are pregnant or breastfeeding.
- for more than 3 weeks - if you have kidney problems - if you have an autoimmune disease.
|
163 | Menthol (Entry 1 of 5) | In dermal preparations containing 1% or less, EXCEPT patches |
|
164 | Menthol (Entry 2 of 5) | In dermal preparations containing more than 1% and up to 5%, EXCEPT patches |
|
165 | Menthol (Entry 3 of 5) | In dermal preparations containing more than 5%, EXCEPT patches |
|
166 | Menthol (Entry 4 of 5) | In dermal patches containing more than 1% and up to 5% |
|
167 | Menthol (Entry 5 of 5) | In dermal patches containing more than 5% |
|
168 | Methyl salicylate (Entry 1 of 2) | In dermal preparations containing 1% or less of methyl salicylate |
|
169 | Methyl salicylate (Entry 2 of 2) | In dermal preparations containing more than 1% of methyl salicylate |
|
170 | Metoclopramide | In medicines for oral use |
|
171 | Methoxamine | In nasal decongestant preparations for topical use |
|
172 | Miconazole (Entry 1 of 2) | In preparations for vaginal use |
|
173 | Miconazole (Entry 2 of 2) | In preparations for topical oral use |
|
174 | Mometasone (Entry 1 of 2) | In preparations for dermal 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.
- 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.
|
175 | Mometasone (Entry 2 of 2) | In nasal spray preparations |
- 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.
- 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 |
|
177 | Naphazoline (Entry 2 of 2) | In topical eye preparations |
|
178 | Naproxen (Entry 1 of 2) | In preparations for oral use in adults and children aged 12 years and over |
|
179 | Naproxen (Entry 2 of 2) | When the preparation includes indications for oral use in children under 12 years of age |
|
180 | Nasal decongestant preparations, including:
| When in nasal decongestant preparations for topical use |
|
181 | Nizatidine | In medicines for oral use |
|
182 | Nutmeg oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
183 | Nystatin | In preparations for vaginal use |
|
184 | Omeprazole | In preparations for oral use |
|
185 | Orange oil (bitter) | For the purpose of exclusion from the schedules to the current Poisons Standard |
|
186 | Oxymetazoline (Entry 1 of 4) | In nasal decongestant preparations for topical use |
|
187 | Oxymetazoline (Entry 2 of 4) (See also vasoconstrictor eye drops) | In topical eye preparations |
|
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 |
|
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) |
- 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 |
|
191 | Paracetamol (Entry 1 of 3) | For the purpose of exclusion from the schedules to the current Poisons Standard |
|
192 | Paracetamol (Entry 2 of 3) | In Schedule 2 or 3 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.
|
193 | Paracetamol (Entry 3 of 3) | In combination with ibuprofen, in medicines for oral use |
|
194 | Pennyroyal oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
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 |
|
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 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.
|
197 | Permanganates (see also Potassium permanganate) | When included in Schedule 6 to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
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 |
- 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 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 |
|
200 | Pheniramine (Entry 3 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 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:
|
- 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 |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with eyes Avoid contact with skin.
|
203 | Phenylephrine (Entry 1 of 7) | In nasal decongestant preparations for topical use |
|
204 | Phenylephrine (Entry 2 of 7) (See also vasoconstrictor eye drops) | In topical eye preparations |
|
205 | Phenylephrine (Entry 3 of 7) | In oral preparations that are NOT indicated for cough, cold or flu |
|
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 |
|
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) |
- 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 |
|
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) |
- 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) - Do not give to children aged between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. |
210 | Pholcodine (Entry 1 of 2) | In oral preparations indicated for cough, cold or flu, and the preparation does not include dosage instructions for children aged under 12 years |
|
211 | Pholcodine (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 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.
|
212 | Piper methysticum | For the purpose of exclusion from the schedules to the current Poisons Standard in medicines for oral use |
|
213 | Podophyllin (Entry 1 of 2) | In liquid preparations OTHER THAN preparations specifically for use on the anal or genital areas |
|
214 | Podophyllin (Entry 1 of 2) | In solid or semi-solid preparations OTHER THAN preparations specifically for use on the anal or genital areas |
|
215 | Podophyllotoxin (Entry 1 of 2) | In liquid preparations OTHER THAN preparations specifically for use on the anal or genital areas. |
|
216 | Podophyllotoxin (Entry 2 of 2) | In solid or semi-solid preparations OTHER THAN preparations specifically for use on the anal or genital areas. |
|
217 | Potassium permanganate | In Schedule 6 to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Corrosive Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes. |
218 | Povidone-iodine | In preparations for dermal use |
|
219 | Promethazine (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 |
- 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 between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
220 | Promethazine (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 |
|
221 | Promethazine (Entry 3 of 5) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- 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 between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
222 | Promethazine (Entry 4 of 5) | In oral preparations indicated for COUGH, COLD OR FLU:
|
- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner.
|
223 | Promethazine (Entry 5 of 5) | In oral medicines indicated for SHORT TERM USE IN INSOMNIA:
(Note: Promethazine medicines indicated for sedation that only include dosage instructions for children aged < 12 years are subject to ‘Promethazine (Entry 2 of 5)) |
|
224 | Propamidine | In medicines for ophthalmic use |
|
225 | Proton pump inhibitors including:
| In medicines for oral use |
|
226 | Pseudoephedrine (Entry 1 of 3) | When the preparation is NOT indicated for use for cough, cold or flu |
|
227 | Pseudoephedrine (Entry 2 of 3) | In oral preparations indicated for cough, cold or flu which DO NOT include dosage instructions for children aged under 12 years |
|
228 | Pseudoephedrine (Entry 3 of 3) | 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) |
- 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. |
229 | Psyllium | In medicines for oral ingestion which include dosage instructions for children |
|
230 | Pyridoxal (see also Vitamin B6, Vitamins) (Entry 1 of 2) | In SINGLE-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose |
|
231 | Pyridoxal (see also Vitamin B6, Vitamins) (Entry 2 of 2) | In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose |
|
232 | Pyridoxine (see also Vitamin B6, Vitamins) (Entry 1 of 2) | In SINGLE- INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose |
|
233 | Pyridoxine (see also Vitamin B6, Vitamins) (Entry 2 of 2) | In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg per recommended daily dose |
|
234 | Pyrithione zinc | In preparations for external use for treatment of the scalp | either
or
|
235 | Rabeprazole | In medicines for oral use |
|
236 | Ranitidine | Medicines for oral use |
|
237 | Rizatriptan | In divided oral preparations for relief of migraine |
- 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.
- 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 other medicines for migraine - if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety - if you are pregnant or breastfeeding.
|
238 | Safrole | When included in a schedule to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with eyes. |
239 | Sage oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
240 | Salbutamol | In metered aerosols or in dry powder formulations |
|
241 | Sassafras oil | When included in a schedule to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Avoid contact with eyes. |
242 | Senega (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 |
|
243 | Senega (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 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.
|
244 | Silver (see also Silver salts) | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
245 | Silver salts (see also Silver) | In smoking deterrents. |
|
246 | Sodium fluoride (see also Fluorides) | In preparations for ingestion when in Schedule 2 to the current Poisons Standard |
|
247 | Star anise oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
|
|
248 | Sulfacetamide | In medicines for ophthalmic use |
|
249 | Sumatriptan | In divided oral preparations for relief of migraine |
- 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.
- 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 other medicines for migraine - if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety - if you are pregnant or breastfeeding.
|
250 | Symphytum spp | In Schedule 5 to the current Poisons Standard |
- READ SAFETY DIRECTIONS. [f] or - READ SAFETY DIRECTIONS BEFORE OPENING AND USING. [f]
Do not use on broken skin Do not use under occlusive dressing.
|
251 | Terbutaline | In metered aerosols |
|
252 | Tetracaine (amethocaine) (Entry 1 of 2) | When included in Schedule 2 to the current Poisons Standard and for dermal use |
|
253 | Tetracaine (amethocaine) (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 |
|
254 | Tetrahydrozoline (Entry 1 of 2) | In nasal decongestant preparations for topical use |
|
255 | Tetrahydrozoline (Entry 2 of 2) (See also vasoconstrictor eye drops) | In topical eye preparations |
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256 | Thyme oil | For the purpose of exclusion from the schedules to the current Poisons Standard when:
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257 | Tioconazole | In preparations for vaginal use |
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258 | Tramazoline (Entry 1 of 2) | In nasal decongestant preparations for topical use |
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259 | Tramazoline (Entry 2 of 2) (See also vasoconstrictor eye drops) | In topical eye preparations |
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260 | Triamcinolone | In topical preparations for the treatment of mouth ulcers | either
or
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261 | Triprolidine (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 |
- 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 between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. |
262 | Triprolidine (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 |
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263 | Triprolidine (Entry 3 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
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- 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 between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. |
264 | Triprolidine (Entry 4 of 4) | In oral preparations indicated for COUGH, COLD OR FLU:
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- Do not give to children between ‘x’ and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner. |
265 | Tymazoline (Entry 1 of 2) | In nasal decongestant preparations for topical use |
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266 | Tymazoline (Entry 2 of 2) (See also Vasoconstrictor eye drops) | In topical eye preparations |
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267 | Vasoconstrictor eye drops including:
| In topical eye preparations |
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268 | Vegetable oil phytosterol esters | In preparations for oral ingestion |
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269 | Vitamin A (See also Vitamins) | In medicines for oral use that are labelled to be used by females of childbearing age containing MORE THAN:
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270 | Vitamin B6
(Entry 1 of 2) (See also Vitamins) | In SINGLE-INGREDIENT preparations containing 200 mg or less but more than 50 mg of [pyridoxine / pyridoxal] per recommended daily dose |
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271 | Vitamin B6
(Entry 2 of 2) (See also Vitamins) | In MULTI-INGREDIENT preparations containing 200 mg or less but more than 50 mg of [pyridoxine / pyridoxal] per recommended daily dose |
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272 | Xylometazoline (Entry 1 of 4) | When in nasal decongestant preparations for topical use |
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273 | Xylometazoline (Entry 2 of 4) (See also Vasoconstrictor eye drops) | In topical eye preparations |
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274 | Xylometazoline (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 |
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275 | Xylometazoline (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) |
- 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. |
276 | Zinc compounds | In preparations for internal use with a recommended daily dose of more than 25 mg of zinc | either
or
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277 | Zolmitriptan | In divided oral preparations for relief of migraine |
- 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.
- 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 other medicines for migraine - if you are taking, or have taken in the last 2 weeks, medicine for depression or anxiety - if you are pregnant or breastfeeding.
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