Information Update - Health Canada proposes revised labelling standard for non-prescription acetaminophen products

Starting date:
September 15, 2015
Posting date:
September 15, 2015
Type of communication:
Information Update
Source of recall:
Health Canada
Identification number:

September 15, 2015
For immediate release

OTTAWA - Health Canada is seeking input on proposed revisions to strengthen the labelling standard for non-prescription acetaminophen products, to help consumers use these products more safely. As communicated in July 2015, this consultation is one of several steps Health Canada is taking to further minimize the risk of liver damage and improve acetaminophen safety.

Acetaminophen is an ingredient used in nearly 500 non-prescription and prescription products in Canada, including headache and pain remedies, allergy medicines, cold remedies, and narcotic pain relievers. While it is used safely by a vast majority of consumers, acetaminophen - like all health products - has risks, especially if too much is taken or if it is taken for longer than directed. Effects can include liver damage and, in severe cases, acute liver failure, which can be fatal.

The aim of the revised labelling standard is to help consumers more easily identify products that contain acetaminophen, understand the liver risks and use products as directed. The proposed revisions for product packages and labels include:

  • a prominent statement declaring the presence of acetaminophen, so that consumers can more easily identify products that contain the drug;
  • plainer language;
  • a new drug facts table that provides dosing instructions, warnings and other safety information in a quick-reference, easy-to-read format;
  • stronger, clearer warnings with respect to liver damage, including stronger warnings about use with alcohol; and
  • clearer and more prominent dosing instructions to help prevent the risk of accidental overdose, including statements that emphasize the maximum daily dose, dose intervals and duration of use (i.e. how much, how often, and for how long a product should be taken).

Labelling standards provide standardized information that companies include on their product packaging and inserts, such as information on dose, intended use, directions for use, warnings, and active ingredients. This proposed standard follows a review that assessed acetaminophen and liver injury in the Canadian context, and builds on previous action to address acetaminophen liver risks including a previous update to the labelling standard in 2009 that added stronger warnings on liver damage.

Canadians, health professionals, patient groups, industry and other interested parties have until November 29, 2015, to provide input on the draft standard, which is available online.

More information for consumers on using acetaminophen safely is available in Health Canada's website.

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