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Found 10 records similar to Labelling requirements for non-prescription drugs guidance document

Federal

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for non-prescription (Over-the-Counter, OTC) drug products. These amendments are commonly referred to as the Plain Language Labelling (PLL) Regulations.

Last Updated: Jul. 7, 2021
Date Published: Sep. 28, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, plain language labelling regulations, non-prescription drugs, 2014 Regulations Amending the Food and Drug Regulations, labelling, packaging and brand names, drugs for human use for non-prescription
Federal

This proposed guidance will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a Facts Table in a standardized format so that consumers can find important product information quickly and easily.

Last Updated: Jul. 7, 2021
Date Published: Sep. 28, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, drug facts table, non-prescription drugs, plain language labelling, important product information
Federal

The Drug Facts Table for Non-prescription Drugs Guidance Document gives direction for designing safe and clear labels and packages.

Last Updated: Sep. 9, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Non-prescription drugs, a new Drug Facts Table, supporting improved labelling
Federal

Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A manufacturer may reference a labelling standard in a drug submission when the product and its labelling are consistent with the information set out in the document.

Last Updated: Sep. 9, 2021
Date Published: Nov. 17, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, labelling standards, drug product, safety and efficacy profile, specific conditions of use
Federal

The Drug Facts Table provides a standardized format and location (on the label) for important product information. This helps consumers find and compare information quickly and easily.

Last Updated: Sep. 13, 2021
Date Published: Aug. 23, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, non-prescription drugs, drug facts table, Non-prescription drugs, product information, standardized format, location, product information
Federal

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.

Last Updated: Sep. 9, 2021
Date Published: Nov. 18, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription Oral Adult Antitussive Cough and Cold, non-prescription oral antitussive products, labelling standard, market authorization, dextromethorphan, dextromethorphan hydrobromide
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Guidance Document, non-prescription, Oral-Adult-Decongestant, cough and cold, labelling standard
Federal

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof.

Last Updated: Sep. 9, 2021
Date Published: Aug. 30, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, category IV monographs, use and labelling requirements, dose, intended use, directions for use, warnings, active ingredients
Federal

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use.

Last Updated: Jul. 7, 2021
Date Published: Sep. 15, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription Drugs, labelling standards, drug product, permissible conditions of use, labelling requirements, dose, intended use, directions for use, warnings
Federal

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.

Last Updated: Sep. 13, 2021
Date Published: Nov. 9, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription, oral, stool softener, laxatives, labelling standard, market, authorization, DIN, products
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