Guidance Document - Non-prescription Oral Adult Decongestant Cough and Cold Labelling Standard

This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for oral decongestant non-prescription products containing phenylephrine hydrochloride as a single ingredient for use in adults and children 12 years of age and older.

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Last Updated April 17, 2026, 17:30 (UTC)
Created April 17, 2026, 17:30 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2017-05-18 00:00:00
open_canada_keywords {"fr": ["Document d'orientation", "sans ordonnance", "décongestionnant oral-adulte", "toux et rhume", "norme d'étiquetage"], "en": ["Guidance Document", "non-prescription", "Oral-Adult-Decongestant", "cough and cold", "labelling standard"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice - Norme d'étiquetage des médicaments décongestionnants pour adultes vendus sans ordonnance contre la toux et le rhume administrés par voie orale
update_frequency as_needed