FDA Reminds Consumers to Always Use Acetaminophen Safely

By: Dale Slavin, PhD

On several occasions, the FDA has asked its expert advisory committees for advice about acetaminophen, which is used to treat pain and fever. Based on this advice and extensive review of the available scientific evidence, the FDA continues to believe that acetaminophen’s benefits outweigh its risks. With that said, however, no medicine is without any risk, and that includes acetaminophen.

Hundreds of over-the-counter (OTC) and prescription medicines contain acetaminophen. Many people taking these products may not be aware they contain this active ingredient. Taking too much acetaminophen can damage your liver. So it’s important to check your products, both OTC and prescription, before taking to see if they contain acetaminophen and to make sure you know how to take safely.

It’s important to know what’s in your medicine so you don’t take more than one medicine containing acetaminophen at the same time by mistake. Acetaminophen can be found alone in OTC products, or in combination with other ingredients. The OTC products that combine acetaminophen with other ingredients often treat the pain and fever that come with conditions like a cold and the flu.  In prescription medicines, acetaminophen is combined with other ingredients to help relieve moderate to severe pain.

Each year, hundreds of people suffer from liver damage associated with taking too much acetaminophen.  Symptoms of acetaminophen overdose may take several days to appear, and the symptoms may seem like the flu or a cold.

To make sure you don’t get too much acetaminophen, look at the labels of all the medicines you plan to use. On OTC medicines the word “acetaminophen” appears on the front of the package and on the Drug Facts label under the “Active Ingredient” section. On prescription medicines, the label may spell-out “acetaminophen” or have a shortened version of it, such as “APAP,” “acet,” “acetamin,” and “acetaminoph.” If you aren’t sure if your medicine contains acetaminophen, ask your health care professional for help.

To help avoid the risk of liver damage, make sure you understand the information provided on the medicine label or the directions given by your health care professional. You’ll need to know:

  • How much you can take at one time
  • How many hours you must wait before taking another dose
  • How many times you can take it each day
  • When you should not take it and when to talk to your health care professional
  • On children’s OTC medicines, the “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give based on his or her age.  If a dose for your child’s age is not listed or you can’t tell how much to give, ask your health care professional what to do.

Acetaminophen can be safe and effective when you use it as directed. Following these tips and remembering to never take – or give – more than one medicine containing acetaminophen in the same day will help lower the risk of liver injury.

And if you do take too much acetaminophen, get medical help right away, even if you don’t feel sick. Call the National Poison Control Center at 1-800-222-1222 or 9-1-1.

For more information on the safe use of acetaminophen and other common pain relievers and fever reducers, visit www.fda.gov/otcpaininfo and www.knowyourdose.org.

Dale Slavin, PhD, is Acting Director of FDA’s Safe Use Initiative

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