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FDA requires new labels for over-the-counter painkillers

  • Story Highlights
  • FDA requires OTC painkillers to carry new warnings on liver damage, bleeding risks
  • New rule covers acetaminophen (Tylenol) and NSAIDs (aspirin and ibuprofen)
  • Ibuprofen is the main ingredient in Motrin and Advil, naproxen and ketoprofen
  • Manufacturers have one year from today's date to re-label their products
By Saundra Young
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WASHINGTON (CNN) -- Over-the-counter painkillers and fever reducers will now carry new labels warning consumers of the potential risks of liver damage and internal bleeding associated with the drugs, according to a final ruling Tuesday by the Food and Drug Administration.

The new warning labels will affect over-the-counter pain relievers including Tylenol, aspirin and ibuprofen.

The new warning labels will affect over-the-counter pain relievers including Tylenol, aspirin and ibuprofen.

The new rule covers acetaminophen, the popular pain medicine also known as Tylenol, and a class of drugs known as nonsteroidal anti-inflammatory drugs or NSAIDs. The most commonly used NSAIDs include aspirin, ibuprofen (the main ingredient in Motrin and Advil), naproxen and ketoprofen. The modified labeling also applies to all products that contain these ingredients, such as cough and cold medicines.

Under the new rule, package labels and bottles must prominently state in highlighted text the drug's ingredients.

For acetaminophen, the label must include bold lettering warning patients about severe liver damage. The new labeling also instructs patients using the blood thinner warfarin to consult their doctor before using acetaminophen.

Bold lettering on NSAIDs labels must warn of severe stomach bleeding.

"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches," said Dr. Charles Ganley, director of nonprescription drugs in the Center for Drug Evaluation and Research. "However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk."

The new labeling for acetaminophen also warns against taking multiple drugs that contain acetaminophen at the same time and exceeding the recommended dosage of the drug. And, it warns that drinking alcohol -- three or more drinks a day -- while using the painkiller can increase the risk of liver damage.

For NSAIDs, the new labels will also caution users that alcohol use and taking the drugs for longer than directed can increase the risk of stomach bleeding. The agency says the use of blood thinning drugs or steroids while taking NSAIDs can also increase the risk of internal bleeding.

The American Pain Foundation is pleased with the new rule. "This ruling will not only help protect consumers using OTC pain medication on a periodic basis," APF said, "But will be especially meaningful for people suffering from chronic pain who may face co-morbid conditions and are taking OTC pain medication along with their prescribed pain medication."

According to the FDA, some manufacturers have already voluntarily started listing some of these risks on their product labels. The new rule gives manufacturers one year from today's date to re-label their products.

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