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Found 10 records similar to Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling Standard
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.
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.
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.
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.
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.
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.
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.
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.
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.
When you buy non-prescription (over-the-counter) medications for you and your family, you need information to help you make an informed choice.