FDA Says OTC Pain Pill Labels Must Be Revised

Law360, New York (April 28, 2009, 12:00 AM EDT) -- Makers of popular over-the-counter pain relievers like Tylenol and Advil must revise their products' labeling within a year to include warnings about potential risks associated with the drugs under a final rule issued Tuesday by the U.S. Food and Drug Administration.

The FDA's final rule covers acetaminophen (Tylenol's active ingredient) as well as nonsteroidal anti-inflammatory drugs like aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve) and ketoprofen.

Manufacturers have to make sure that the active ingredients of these drugs are “prominently displayed” on labels on both packages and...
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