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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
FDA Press Releases , 04/29/09

The Food and Drug Administration issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs. Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

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