FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers
to Help Consumers Use Products Safely
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).
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. Read more...
