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Propoxyphene Napsylate plus Acetaminophen Combination for Pain

The FDA has approved propoxyphene napsylate and acetaminophen (Darvocet A500™, AAIPharma) for the treatment of mild to moderate pain. Darvocet A500™ is the only approved propoxy-phene napsylate/acetaminophen combination product that contains a lower dose (500 mg) of acetaminophen combined with 100 mg of propoxyphene napsylate. (Darvocet-N® 100 contains 100 mg of propoxyphene and 650 mg of acetaminophen.)
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The new product is expected to provide a unique formulation with the safety benefits of less acetaminophen and the full strength of propoxyphene. The FDA has established a 4,000-mg maximum daily dose of acetaminophen for adults, and physicians are concerned about patients who self-medicate using over-the-counter products.

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