Change coming to OTC Acetaminophen Products to Emphasize Risk of Liver Damage

On September 15th 2016, Health Canada announced that they have updated the Labelling Standard for the over-the-counter drug acetaminophen.  Being one of the most commonly used pain and fever relievers in Canada, acetaminophen can be found in cold remedies, allergy medication, and headache and pain remedies.  While it has been safely used by the majority of the population, a known risk of acetaminophen is the possibility of liver damage.

Changes coming to the Labelling Standard include:

  • The words “contains acetaminophen” will be in red text and bolded in the top right corner on the front of the package to make the consumer more aware of what products contain the active ingredient
  • New Drug Facts table
  • Instructions on the package will emphasize using the lowest effective dose, not going over the daily maximum dose (4000 mg in adults in a 24 hour period), not using acetaminophen products for no more than 3 days for a fever and 5 days for pain, and to not mix with alcohol if drinking over two drinks in a day
  • The recommendation that a calibrated device to be included with children’s liquid products containing acetaminophen

New products that companies are trying to introduce to market will have to comply with these requirements immediately.  Products that are already on the Canadian market are expected to comply and update their product labels within 18 months. By 2021 all products will require the Drug Facts table.

If you wish to read further on changes to labeling practices in Canada, more can be read here.  As qualified Drug Regulatory and Packaging Development Consultants we are very well versed with these products and their regulations in Canada and in the United States.  Feel free to contact Focal Point Research so we can help your packaging comply with current regulations.