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FDA Approves Aleve PM

FDA Approves Aleve PM (diphenhydramine hydrochloride and naproxen sodium)

January 16, 2014 -- The The United States Food and Drug Administration (FDA) has approved Aleve PM (diphenhydramine hydrochloride and naproxen sodium), an over-the-counter antihistamine and nonsteroidal anti-inflammatory drug (NSAID) combination for the relief of occasional sleeplessness associated with minor aches and pains.

Aleve PM contains the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium (contained in Aleve) which has been known to cause allergic reactions and stomach bleeding. It also contains the antihistamine diphenhydramine hydrochloride (contained in Benadryl) which can cause drowsiness.

Always read the directions for use carefully and check with your doctor or pharmacist if you have any concerns.

Aleve PM is distributed by Bayer HealthCare LLC, Consumer Care in Morristown, NJ.

Posted: January 2014

Aleve PM (diphenhydramine hydrochloride and naproxen sodium) FDA Approval History