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ARGOM Appendix 5: Guidelines on OTC applications for specific substances
Note: This guidance document contains references to warning statements that are being included in the current updating of the RASML document. Warning statements marked with an (*) which are included in the updated version of the RASML document will be removed from this guidance document once the updated RASML is implemented.
The dose for adults and children 12 years and over of preparations containing caffeine for use as a stimulant or alerting agent should be consistent with the following:
- 100 mg per dose maximum, which may be repeated at three hourly intervals. Do not exceed 600 mg in 24 hours.
Labels of products containing caffeine should advise users to limit their total caffeine intake from all sources (including tea, coffee or other products containing caffeine), and should provide information regarding the amount of caffeine per dose of the product relative to the caffeine content of a cup of coffee for example a statement such as the following should be included on the label:
- Limit the use of caffeine-containing products (including tea and coffee) when taking this product. One tablet/capsule contains about the same amount of caffeine as x cups of instant coffee.
The Food Standards Australia New Zealand (FSANZ) website states that a 250 mL cup of instant coffee (1 teaspoon/cup) contains 60-80 mg caffeine.
Caffeine is a Central Nervous System (CNS) stimulant and may cause sleeplessness in susceptible people if it is taken up to several hours before going to bed (doses of 50-200 mg can increase alertness and can decrease fatigue and drowsiness). Therefore, a label warning such as the following should also be included:
- Caffeine may cause sleeplessness if it is taken up to several hours before going to bed.
Inclusion of caffeine as an ingredient in multi-component products should be justified with clinical efficacy and safety data (as outlined in ARGOM Appendix 5 Guidelines on efficacy and safety aspects of OTC applications: Section 9 Fixed combination products).
Weight control preparations containing caffeine will not be approved.
The directions for use for dermal preparations containing camphor should indicate that the product is not to be applied to infants under 12 months of age unless on the advice of a doctor or pharmacist.
Registration of steam inhalant solutions containing camphor will not be approved unless appropriate supporting clinical efficacy and safety data are provided.
Adverse reactions have been reported following repeated application of creams containing more than 1% cetrimide. Topical products containing more than 1% cetrimide will not be approved for registration unless appropriate supporting clinical efficacy and safety data are provided.
The use of chest rubs will not be accepted for the treatment of bronchial conditions. The only indications that will be accepted for chest rubs containing ingredients such as eucalyptus oil, menthol, camphor and other aromatics are:
- May relieve the nasal congestion of colds and make breathing easier (or similar wording).
The directions for use of chest rubs should include the following statement:
- Do not apply to infants under 12 months of age unless on the advice of a doctor or pharmacist.
- Rub on the chest and/or the throat.
- Do not use on the face or anywhere near or in the eyes or nostrils.
Adverse allergic reactions have been reported for products containing chlorhexidine for use on oral mucosal surfaces. Therefore the labels of products containing chlorhexidine when included in preparations for human use, including preparations for topical use on mucosal surfaces should include warning statements consistent with the following:
- *Avoid contact with eyes.
- *If in eyes, rinse well with water.
- *Warning - This product contains chlorhexidine. Severe allergic reactions can occur. Stop use if this occurs.
For topical products containing chlorhexidine for human use but does NOT include use on mucosal surfaces, statements should be consistent with the following:
- *Avoid contact with eyes.
- *If in eyes, rinse well with water.
- *Mild irritation may occur; stop use if it becomes severe.
Where products containing chlorhexidine for application to mucous membranes have a Product Information (PI) document, the PI should advise of the potential for hypersensitivity reactions to chlorhexidine in both the 'Adverse effects' and 'Contraindications' sections.
Coal tar preparations
All coal tar preparations contain mutagens and are potentially carcinogenic. Justification for the inclusion of coal tar in terms of benefit versus risk should be provided. Indications for use in minor conditions (e.g. napkin rash) will not be accepted.
Because of the potential for increased absorption associated with the use of coal tar under occlusive dressings, the labels (and the CMI and PI, and any package insert, where these are provided) of all topical products containing coal tar should include a warning such as:
- Not to be used under occlusion except on medical advice.
The use of a light bandage to prevent staining of clothes is acceptable.
This advice need not be included on the labelling of shampoos or other products which are designed to be washed off after application.
The safety of coal tar on children under 2 years of age has not been established. In addition, although no human data are available on the effects of using coal tar during pregnancy or lactation, the presence of mutagens in the urine has been reported following topical application of coal tar8. The labels (and the CMI and PI, and any package insert, where these are provided) of all topical products containing coal tar should therefore include warnings such as:
- Not recommended for use on children under 2 years of age except under the direction and supervision of a doctor.
- Not recommended for use during pregnancy or while breastfeeding.
As coal tar may cause hypersensitivity reactions and irritation, labels of products containing coal tar should also include warnings such as the following:
- *If irritation occurs, discontinue use.
- *Avoid contact with the eyes.
- *Do not use for prolonged periods except on the advice of a doctor.
In addition, unless otherwise justified, products that are intended for use in psoriasis should include a warning such as:
- Do not use this product with other forms of psoriasis therapy such as UV radiation or prescription drugs unless directed to do so by a doctor.
Where provided, the Product Information for codeine-containing products should include:
- Under 'Pharmacokinetics' ('Metabolism'): A statement advising that about 8% of patients metabolise drugs poorly via Cytochrome P450 2D6 (CYP2D6), and are likely to obtain reduced pain relief from codeine due to reduced formation of the active metabolite, morphine; and
Note: the 'Pharmacokinetics' section of the Product Information should specifically state that codeine's active metabolite is morphine.
- Under 'Precautions' - 'Interactions with other medicines': A statement advising of the possibility of interactions between codeine and drugs that can inhibit CYP2D6, such as quinidine, phenothiazines and antipsychotic agents.
The CMI for codeine-containing products should advise that about 8% of people are poor metabolisers of codeine, and that poor metabolisers are likely to obtain less pain relief with codeine compared with other people who are not poor metabolisers.
For products which are indicated for the treatment of corn, statements such as the following should be included on labels:
- Do not use if you have diabetes or impaired circulation.
- Do not use on infants or very young children unless on medical advice.
Corticosteroid nasal sprays
Some low dose aqueous corticosteroid nasal sprays are scheduled as OTC medicines. Restrictions on dose, pack size and indications (including duration of use and age group) are included in the relevant Schedule entry in the Standard Uniform Scheduling of Medicines and Poisons (SUSMP).
The safety and efficacy data required to support the registration of OTC corticosteroid nasal sprays are as indicated in the ARGPM Appendix 19 Metered dose aerosols (pressurised and non-pressurised).
Information consistent with the following should be included either on the product label or in a package insert (e.g. in the CMI, if it is provided as a package insert):
- Do not exceed the maximum stated dose.
- A lower maintenance dose should be used once full effect is obtained.
- 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
- 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.
Where this information is included in the CMI or other package insert, the label should include a statement such as:
- Read the enclosed CMI leaflet before starting to use this product (or Read the enclosed leaflet before starting to use this product).
Decongestant products, nasal
Rebound nasal congestion can occur as a result of continued use of topically administered decongestant nasal products. Such products should contain a statement advising against prolonged use such as:
- If congestion persists for more than a few days, seek medical or pharmacist advice.
Decongestant products, oral
Because of the unpredictable effect that sympathomimetic amines (e.g. pseudoephedrine and phenylephrine) may have on blood pressure and the risk of interactions with antidepressant medication, product labels should include a warning statement such as:
- *See your doctor before taking this product if you have high blood pressure or heart problems or are taking antidepressant medication.
Pseudoephedrine is a central nervous system stimulant and may cause sleeplessness if it is taken up to several hours before going to bed in susceptible people. Therefore, the labels of all products that contain pseudoephedrine (including products that also contain a sedating antihistamine or any other ingredient that may have a sedative effect in some people) should include a warning such as:
- *This product/ [product name] may cause sleeplessness if it is taken up to several hours before going to bed.
Labels for all products should include a statement such as:
- If diarrhoea persists, seek medical advice.
In infants aged 6 months and under, diarrhoea which persists for longer than six hours requires medical attention, because of the life-threatening consequences of dehydration.
For children aged between 6 months and 3 years, diarrhoea which persists for longer than twelve hours requires medical attention. Although medical consultation is preferable to home treatments, oral rehydration products (electrolyte replacement products) can serve a useful role in reducing the consequences of diarrhoea in this age group.
Children aged 3 years and over should be treated for diarrhoea for only short periods before medical advice is sought.
The directions for use on the labels of products for use as diarrhoea treatments should include the following information:
- For children under 6 months of age: Medical advice should be sought if diarrhoea persists for more than 6 hours;
- For children aged 6 months to under 3 years: Medical advice should be sought if diarrhoea persists for more than 12 hours;
- For children aged 3-6 years: Medical advice should be sought if diarrhoea persists for more than 24 hours;
- For children aged over 6 years: Medical advice should be sought if diarrhoea persists for more than 48 hours.
The label or CMI should include a description of the symptoms of dehydration for the benefit of consumers.
Where inorganic adsorbing agents (such as kaolin) are included in a formulation, evidence should be included to show that any other active ingredient is not irreversibly adsorbed or inactivated by the agent. In the absence of supporting clinical data, simple adsorbent preparations for the treatment of diarrhoea will not be registered.
It is considered that there is insufficient evidence to support the use of solanaceous alkaloids in the treatment of diarrhoea in adults or children.
See also 'Electrolyte replacement products'
- Wheeler LA, Saperstein MS & Lowe NJ. Mutagenicity of urine from psoriatic patients undergoing treatment with coal tar and ultraviolet light. J Invest Dermatol 77:181-185; 1981.