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FDA Adds 'Doctor' To CV Statement For OTC Aspirin Labeled With Hearts

 
• By Malcolm Spicer

In response to the US agency's guidance announced Nov. 6, the pharmaceutical firm whose name is synonymous with the ingredient aspirin, Bayer, says it is considering how it will change labeling now used for most Bayer Aspirin products that includes a statement similar to the recommended language.

Guidance word in red keyboard buttons

OTC aspirin makers often use cardiovascular imagery on packages to attract consumers interested in using the products to help reduce chances of a heart attack or stroke. FDA now is instructing US marketers to include information more pointedly suggesting that these consumers consider first seeking physician advice,

In final guidanceannounced Nov. 6, FDA makes clear that it not only expects OTC aspirin marketers to include...

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