Labels for Non-Prescription Drugs

Labels on non-prescription drugs and health products provide important information, but it’s not always clearly organized or easy to understand. A year ago, Health Canada released new guidance for non-prescription (i.e. over-the-counter) drugs labels to make it easier for Canadians to read and understand. Improved labels minimize the risk of confusion and harmful medication mistakes.

The label applies to thousands of non-prescription drug products in Canada and is called the “Drug Facts” table. The requirement is effective for new products starting June 2017 with all non-prescription health products expected to carry a Facts Table by June 30, 2021.

Companies producing natural health products (e.g., vitamins, herbal products, and minerals), while not subject to the regulations, are being provided with guidance for adopting a Facts Table, called the “Product Facts” table, on their product labels as a best practice.

You can buy a non-prescription drug without a doctor’s prescription. To use it safely you have to know if this drug interacts with other medicines, has any side effects and how much you have to take to avoid overdose. Some medicines should only be used by adults; some should not be used during pregnancy. Drugs can be very helpful when used properly but can cause serious problems if used incorrectly.

For any health product you buy for you or your family, reading the label is important for helping you choose the right medication and know how to use it properly and safely.

The Drug Facts Table is a table included on the outer label or package of non-prescription medications (such as cough syrups, pain and fever relievers and allergy remedies) to help you easily find important information. The label aims to make information more uniform and easier to find.

Through Health Canada’s Plain Language Labelling Initiative, regulations have been introduced with new industry requirements for health product labelling and packaging, including a requirement for a Facts Table on the outer label of non-prescription drugs.

Modelled after Canada’s Nutrition Facts table on foods and the Drug Facts box used on non-prescription drugs in the U.S., the new table uses simple language and an easy-to-read format to help consumers:

• compare and choose products
• identify the active ingredient(s) and their purpose, including the amount in each dosage unit which can help avoid the risk of accidentally overdosing by taking more than one product with the same active ingredient
• quickly know what the product is used for
• quickly locate the warnings, including when the product should not be used
• easily locate the directions for use, including when, how and how often to take the product
• identify inactive ingredients, which is important for avoiding potential allergic reactions
• know how to contact the manufacturer with product questions or concerns

Shown above: Sample Drug Facts table for a product containing the active ingredient guaifenesin

If you read a health product label and still have questions about the product, talk to your pharmacist, doctor, or other health care professional.

References:

• http://news.gc.ca/web/article-en.do?nid=1092639
• http://news.gc.ca/web/article-en.do?nid=1092509&tp=1
• https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html
• https://www.canada.ca/en/health-canada/services/drug-facts-table.html