FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers

The Food and Drug Administration proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscle aches. Click for Questions and Answers on Proposed rule for Labeling Changes to Over-the-Counter Pain Relievers. www.fda.gov/bbs/topics/NEWS/2006/NEW01533.html.