A new label standard for oral dextromethorphan has been posted for consultation on Health Canada’s website. This label standard has been developed in association with the Australian authorities (TGA) in an effort to increase regulatory harmonization and alignment between the two regulators. The proposed Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard describes the requirements necessary to receive approval in Canada (DIN) for oral antitussive non-prescription products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient.
Does your product qualify?
- Eligible products are those intended to relive the symptoms of a common cold, and to be used by adults and children 12 years of age and older.
- In order to receive approval the statements on your label must match those in the proposed label standard.
Here are some highlights of the new label standard for dextromethorphan:
4.1 Acceptable Uses: Antitussive / cough suppressant
Temporary relief of dry cough due to:
- minor bronchial irritation occurring with a cold/common cold
- minor throat and bronchial irritation occurring with a cold/common cold
Refer to Section 5.1 below for dosing for dextromethorphan products.
5.1 Dosage for Adults and children 12 years of age and older.
|Therapeutic Class||Medicinal ingredient||Recommended Single Dose||Dose Interval||Maximum Daily Dose|
|Antitussive||Dextromethorphan OR Dextromethorphan hydrobromide||10-20 mg||every 4 hours||120 mg|
|30 mg||every 6-8 hours|
Don’t forget to consult the labelling standard to guide you on the necessary warning statements for your dextromethorphan product.
Look out for more label standard postings in the near future as additional categories of over-the-counter products are planned for review by Health Canada and the Australian authorities.