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

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. 2021-09-13 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNon-prescriptionoralstool softenerlaxativeslabelling standardmarketauthorizationDINproductsdocusate sodiumdocusate calciumoccasional constipation Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling StandardHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/nonprescription-drugs-labelling-standards/non-prescription-oral-stool-softener-laxatives-labelling-standard.html Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling StandardHTML 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-laxatifs-emollients-vente-libre-administres-voie-orale.html

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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