FDA Requires Warnings on IAAA Products

The FDA has reissued a final rule requiring additional warnings on OTC internal analgesic, anti-pyretic and anti-rheumatic (IAAA) drug labeling. IAAA products marketed under an OTC drug monograph or approved NDA must warn consumers about acetaminophen’s risk of liver injury and nonsteroidal anti-inflammatory drugs’ risk of stomach bleeding. All warnings must be displayed on the outer carton, and organ-specific warnings should be on the container of the product, according to the final rule.
Washington Drug Letter