Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling Standard

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for oral stool softener laxative non-prescription products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older to relieve occasional constipation.

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Last Updated April 17, 2026, 17:35 (UTC)
Created April 17, 2026, 17:35 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-11-09 00:00:00
open_canada_keywords {"fr": ["Laxatifs", "émollients", "fécaux oraux", "en vente libre", "norme d'étiquetage", "autorisation", "de mise", "en marché", "DIN", "laxatifs", "docusate de sodium", "docusate de calcium", "constipation occasionnelle"], "en": ["Non-prescription", "oral", "stool softener", "laxatives", "labelling standard", "market", "authorization", "DIN", "products", "docusate sodium", "docusate calcium", "occasional constipation"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice : Norme d'étiquetage des laxatifs émollients en vente libre administrés par voie orale
update_frequency as_needed