Guidance Document - Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard (English, HTML)

View metadata and access the original English HTML file: Guidance Document - Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard.

Format

HTML

Access

file-only

Publisher-reported update

2021-09-09

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for non-prescription oral antitussive products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults and children 12 years of age and older to relieve symptoms of the common cold.

Access original file