FDA Advises Consumers to Always Use Acetaminophen as Directed

The U.S. Food and Drug Administration wants consumers to know that taking more than the recommended dose of acetaminophen could potentially cause serious liver damage or even death. 

Dentists routinely manage acute dental pain in patients. In some cases, they recommend that patients begin using over-the-counter acetaminophen before visiting their dentists for treatment.

Acetaminophen is the generic name of the active ingredient in over-the-counter products such as Tylenol, and the prescription drugs Vicodin and Percocet. It is found in more than 600 OTC and prescription pain relievers and fever-reducers, cold and flu, allergy, and sleep-aid medicines, according to the FDA.

When used as directed, the drug is safe and effective, but “even taking even a little more than directed, or using more than one medicine that contains acetaminophen” could be fatal. 

The FDA cautions patients to always follow their doctor’s directions as well as the directions on the medicine label when using products containing acetaminophen. It's especially important that patients talk to their doctor if they regularly drink alcohol or have already been diagnosed with liver disease. The agency also advises patients taking warfarin—a common blood thinner—to discuss taking acetaminophen with a doctor because the combination may raise the risk of bleeding.

When giving the medicine to children, FDA recommends parents:

  • Check the active ingredients in all other medicines the child is taking;
  • Read the information given by the child’s doctor and as well the information on the OTC Drug Facts label or prescription label and follow directions;
  • Choose the right medicine based on the child’s weight and age to determine if the medicine is right for your child, how much medicine to give, how many hours to wait before giving another dose and when to stop giving acetaminophen and ask a doctor for help. If a dose for your child’s weight or age is not listed on the label, or you can’t tell how much to give, ask your pharmacist or doctor what to do;
  • Do not use a spoon because it may give the wrong amount. Use the measuring tool that comes with the medicine to get the exact dose. If no measuring tool, ask a pharmacist;
  • Never give more than one medicine that contains acetaminophen. If you give more, it could harm your child.

In the case that the medicine doesn't relieve pain or fever in children or adults, FDA urges patients to not take any more acetaminophen but to talk to a doctor, nurse or pharmacist.

For more information about acetaminophen as well as a question-and-answer page for patients, visit “ www.fda.gov/ForConsumers/ConsumerUpdates/ucm168830.htm”.

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