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Health Canada Releases Updated Labeling Standard for OTC Acetaminophen Products

October 13, 2016

Health Canada has released Revised Guidance Document: Acetaminophen Labelling Standard to assist consumers on using these products safely.

Acetaminophen is a drug available in both non-prescription and prescription products. It is used in headache and pain remedies, allergy medicines, cold remedies, and opioid pain relievers.

The revised labeling standard includes the following improvements:

  • Clearer instructions on packages that emphasize the importance of using the lowest effective dose; not exceeding the recommended daily maximum (which is 4,000 mg for adults) in a 24-hour period; using these products for no more than five days for pain or three days for fever; and not mixing them with alcohol if drinking three or more drinks in a day;
  • Displaying the words “contains acetaminophen” in bold, red text in the top right corner of the front of the package to make it easier for consumers to know if a product contains this drug
  • A new Drug Facts table for packages to provide product instructions, warnings and other safety information in a consistent, quick-reference format
  • A recommendation that all children’s liquid products include a calibrated dosing device, so parents and caregivers can be sure that they’re giving their child the right amount.

This labeling standard will be enforced on March 1, 2018 for all products.