NHPD Standard Labeling Requirements
Standard labeling requirements, which are established to ensure that consumers can make informed choices, include:
• the product name and the quantity of product in the bottle;
• recommendations of conditions of use including its recommended purpose,
recommended dosage and dosage form and route of administration;
• any cautionary statements, warnings, contra-indications and possible adverse
reactions associated with the product. The Regulations require product license
holders to monitor all adverse reactions associated with their product. Serious
adverse reactions are reported to Health Canada. The adverse reaction reporting
assists Health Canada in issuing advisories, where appropriate, to the public.
• any special storage conditions required by the products.
