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Found 10 records similar to Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard

Federal

This labelling standard describes the requirements necessary to receive marketing authorization (Drug identification number (DIN)) for oral expectorant nonprescription product containing guaifenesin as a single ingredient for use in adults and children 12 years of age and older to relieve symptoms of common cold.

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription oral adult expectorant cough and cold, labelling standard, market authorization, dextromethorphan, dextromethorphan hydrobromide
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

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
Federal

This labelling standard describes the requirements necessary to receive market authorisation ( Drug identification number (DIN)) for nonprescription topical nasal decongestant products containing oxymetazoline hydrochloride or xylometazoline hydrochloride as a single ingredient for use in adults and children 12 years of age and older to relieve nasal congestion.

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription topical nasal decongestants, labelling standard, market authorisation, oxymetazoline hydrochloride, xylometazoline hydrochloride
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

Health Canada Revised Guidance Document - Acetaminophen Labelling Standard

Last Updated: Jun. 1, 2021
Date Published: Sep. 15, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, revised, acetaminophen labelling standard
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 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

The safe use of non-prescription drugs depends on consumers being able to identify the desired product and also being able to understand and act upon the information presented. The label and package are the first points of interaction between a health product and a consumer or healthcare professional. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This guidance document provides prescriptive information on the design specifications, required sections of the CDFT, and labelling content.

Last Updated: Jul. 7, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Labelling requirements, non-prescription drugs, safe use of non-prescription drugs, guidance document, label and package, a health product and a consumer, a health product and healthcare professional, plain language labelling
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