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