Description

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.

Resources

Name	Format	Description	Link
Guidance Document - Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/nonprescription-drugs-labelling-standards/non-prescription-oral-adult-antitussive-cough-cold-labelling-standard.html
Guidance Document - Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/medicaments-vente-libre-normes-etiquetages-produits-pharmaceutiques/norme-etiquetage-medicaments-adultes-vendus-sans-ordonnance-contre-toux-rhume-administres-voie-orale-2.html

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