Pain :: Label changes for products containing NSAIDs

To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes for products containing NSAIDs:

To require new warnings for products that contain an NSAID which would highlight the potential for stomach bleeding in persons over age 60, in persons who have had prior ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for longer time than directed; and

To require that the name of the NSAID ingredient and the term “NSAID” be prominently identified on the product’s PDP of the immediate container and the outer carton (if applicable).

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