www.fdanews.com/articles/122574-fda-amends-labeling-requirements-for-nsaid-warnings
FDA Amends Labeling Requirements for NSAID Warnings
November 30, 2009
Manufacturers of OTC acetaminophen and nonsteroidal
anti-inflammatory drugs (NSAIDs) do not have to put a warning about acetaminophen’s risk of
liver injury and NSAID-related stomach bleeding on each blister unit of a blister card, according to an amended
final rule. In an amendment to its final rule on the products’ labeling, the FDA tells drugmakers that they only need to put the appropriate
warning on the blister card if the warning remains intact and readable when the drug is removed from the card.
Washington Drug Letter
Washington Drug Letter