Meeting requirements for over-the-counter (OTC) medicines containing dextromethorphan hydrobromide

This monograph only applies to medicines containing dextromethorphan hydrobromide (CAS no. 6700-34-1) and excludes preparations containing any other salts and derivatives of dextromethorphan.

Acceptable dosage forms and strengths are shown in the table below.

Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)

Cough suppressant for the temporary relief of non-productive cough.

For lozenges, 'helps soothe sore throats' may be included.

Label indications

Temporary relief of dry cough.

The following may also be included:

• Qualification with 'due to common colds'.
• Further description of the cough with one or more of the following terms: non-productive/irritating/stubborn/tickly.
• Relieves dry coughs by suppressing the urge to cough

The following label claims are also acceptable:

• For lozenges:
  • Helps soothe sore throats
  • Fast/rapid relief from dry cough
• For oral liquid:
  • Long lasting relief for up to 8 hours (for those with 30 mg single dose every 6-8 hours frequency)
  • Fast/rapid relief from dry cough

Dosages must be as shown in the following table.

*only on the advice of a doctor, pharmacist or nurse practitioner.

*only on the advice of a doctor, pharmacist or nurse practitioner.

Include the following for all dosage forms:

• Do not give to children under 6 years of age.
• If the medicine is not to be indicated for children below 'x' years of age (where 'x' is any age between 6 and 11 years of age), then the label must contain the statement "Do not give to children under 'x' years of age" as required by the Required Advisory Statements for Medicine Labels (RASML).

Advisory statements

The following advisory statements are required:

• If coughing persists, consult your doctor or pharmacist.
• Do not take this medicine if you are taking a monoamine oxidase inhibitor (MAOI) or an antidepressant or have taken the MAOI or antidepressant medicine within the past two weeks.

Labelling must comply with all relevant Australian requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.

In addition to the quality requirements outlined in the document Requirements for OTC new medicine N2 applications, the following specific requirements apply to dextromethorphan hydrobromide monograph medicines:

Finished product specifications

In addition to other requirements specified in the document Requirements for OTC new medicines N2 applications, the finished product specifications must comply, at a minimum, with the relevant set of requirements below.

The requirements below include relevant BP general monograph/USP General Chapter requirements and TGO78 requirements. References to pharmacopoeial monographs below refer to the current monograph at time of application.

For lozenges, the following tests and limits:

• organoleptic properties such as lozenge appearance, odour, taste, etc
• identification of dextromethorphan hydrobromide
• dextromethorphan hydrobromide content of 92.5 - 107.5%
• uniformity of dosage units (BP)
• microbiological quality in compliance with TGO 77.

For oral solutions, the tests and limits in the USP monograph Dextromethorphan Hydrobromide Oral Solution with the addition of:

• organoleptic properties such as solution appearance, odour, taste, etc
• content of any preservatives included in the formulation
• pH
• microbiological quality in compliance with TGO 77.

Container/measuring device

• Dextromethorphan medicines must be sold in containers that comply with Therapeutic Goods Order No 80, Child Resistant Packaging Requirements for Medicines.
• If a measuring device is to be supplied with the medicine, calibrations must be exclusively in metric units and must allow all the doses shown on the labels to be measured accurately. Details of the calibrations on the measuring device must be provided with the submission (a sample may also be requested). Further considerations and requirements regarding measuring devices are detailed in ARGOM Appendix 2: Guidelines on quality aspects of OTC applications, 8. Finished product container.