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FDA sets limits on acetaminophen

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Acetaminophen is a drug used for pain relief and fever reduction that is available in over-the-counter and in prescription medications. When used as directed, it is considered safe and effective, but when used improperly it can lead to liver damage and liver failure.

Over the next three years, the FDA will limit the amount of acetaminophen in prescription medications to 325 milligrams per dose in order to make the prescription products safer for consumers. Overdose of prescription medications containing acetaminophen account for almost half of the acetaminophen related liver failures in the United States.

The greatest risk of liver damage occurs when patients misuse acetaminophen containing medications. The most common misuses of acetaminophen are: taking more than the prescribed dose, taking more than one acetaminophen containing medication at the same time, or drinking alcohol while taking acetaminophen.

The new limitations will not affect any of the over-the-counter acetaminophen containing medications.

Patients with questions are encouraged to discuss their concerns with their health care providers.

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