Stronger, clearer labels for over-the-counter acetaminophen products to further address the risk of liver damage
- Starting date:
- September 15, 2016
- Posting date:
- September 15, 2016
- Type of communication:
- Information Update
- Drugs, Affects children, pregnant or breast feeding women
- Source of recall:
- Health Canada
- Labelling and Packaging
- General Public
- Identification number:
OTTAWA – Health Canada is releasing an updated Labelling Standard for over-the-counter acetaminophen products to help consumers use these products more safely. Product packages will include clearer instructions and stronger warnings to help reduce the potential for liver damage. This change is one of a number of steps Health Canada is taking in light of a safety review released in 2015.
Acetaminophen is a drug used in a wide range of non-prescription and prescription products, including headache and pain remedies, allergy medicines, cold remedies, and opioid pain relievers. With hundreds of different products available, it is one of the most commonly used pain and fever relievers in Canada.
Acetaminophen is used safely by the vast majority of Canadians. But like most health products, it can have risks, especially if too much is taken or if it is taken for longer than directed. These risks include liver damage, which in severe cases can lead to liver failure and even death.
Improvements to the Labelling Standard include:
- 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; and
- 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.
The revised standard and the recommendation for children’s dosing devices address recommendations coming out of the safety review. As an added safeguard, Health Canada is also issuing a Notice to industry advising of a policy to limit the amount of acetaminophen in prescription combination products (that is, products that also contain other drugs) to no more than 325 mg. No prescription products on the market currently contain more than 325 mg, but the action will discourage future products. Health Canada has also initiated ongoing work with stakeholders to raise public awareness of the risks of acetaminophen.
The label changes apply immediately to new products that companies are looking to introduce into the Canadian market. Companies with products already on the market are expected to update their product labels within 18 months. The Drug Facts table will be required on all products by 2021.
Other risk mitigation strategies considered in discussion with patient, consumer, health professional and industry stakeholders, such as reducing the recommended daily maximum or the unit dose for some products, will not be pursued at this time due to a lack of scientific evidence that these strategies would improve overall safety and concerns about possible negative impacts on consumers, such as driving them to other pain and fever relievers that have their own risks and may be less appropriate for them.
Health Canada continues to monitor acetaminophen’s safety and to raise awareness of its risks, as it does for all drugs available in Canada. If new information emerges suggesting the need for further action, Health Canada will consider and act on it as necessary.
What you should do
- Always read the product label and follow the instructions. Know if the product contains acetaminophen, the amount to take, when and how often to take it, and when to stop.
- Take the smallest amount that works for you. Never take more than the maximum daily dose. The amount you can safely take may be less than what is recommended on the label if you have risk factors like liver disease or drink three or more alcoholic drinks in a day.
- Take only one acetaminophen product at a time. Acetaminophen is in many products and you could accidentally take too much if you’re using more than one product at the same time.
- Talk to a health professional if you have any questions about acetaminophen. More information for consumers on acetaminophen is available on Health Canada’s website.
For more information
- Using Acetaminophen Safely
- Acetaminophen Labelling Standard for non-prescription products
- Notice to industry: Limiting the strength of acetaminophen to 325 mg per dosage unit in combination prescription products
- Summary - Stakeholder engagement sessions on the safe use of acetaminophen
- For a listing of acetaminophen products, search for the active ingredient “acetaminophen” in Health Canada’s Drug Product Database
- Date modified: