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Label Warnings Against Driving Start Arriving For OTC Sleep Ingredients In US

 
• By Malcolm Spicer

Unisom Sleeptab with 25 mg doxylamine is first OTC sleep remedy adding warning not to drive a vehicle or operate machinery and five others FDA requested in “changes being effected” letter. Agency’s ongoing review found “labeling deficiencies” with doxylamine and diphenhydramine.

• Source: Shutterstock

The US Food and Drug Administration didn’t sleep on changes needed in labeling for Unisom Sleeptab and coming for other OTCs formulated with doxylamine or diphenhydramine, including analgesics also containing either of the sleep ingredients.

The FDA Center for Drug Evaluation and Research contacted Sanofi’s US business marketing the Unisom brand, Chattem Inc., a...

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