Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard

Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard This Labelling Standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for single and multiple-ingredient orally administered nonprescription paediatric products for use in children 6 to under 12 years of age to provide relief of symptoms associated with the common cold. 2021-09-13 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNon-prescriptionoralpaediatriccough and coldlabelling standardmarketingauthorizationDINorally administeredpaediatric productscommon cold Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling StandardHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/nonprescription-drugs-labelling-standards/nonprescription-oral-paediatric-cough-cold-labelling-standard.html Guidance Document: Nonprescription Oral Paediatric Cough and Cold 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-medicaments-pediatriques-vente-libre-contre-toux-rhume-administres-voie-orale.html

This Labelling Standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for single and multiple-ingredient orally administered nonprescription paediatric products for use in children 6 to under 12 years of age to provide relief of symptoms associated with the common cold.

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