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The FDA has been taking action to protect consumers from the risk of severe liver damage posed by ingesting too much acetaminophen. All manufacturers of prescription combination drug products that contain 325 milligrams (mg) of acetaminophen have stopped marketing these products.

These products were discontinued and are no longer available; however there are some remaining manufacturers that are yet to take the necessary action to withdraw their applications.

The FDA recently issued two Federal Register notices to formally withdraw the applications for all prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit. The first notice immediately withdraws FDA approval of those products for which the manufacturers asked to voluntarily withdraw their applications. The second notice addresses the applications of six manufacturers who have discontinued marketing their products but have not correctly withdrawn their applications, and announces FDA’s intention to begin a process to withdraw approval of those applications.

Many consumers are unaware that several of the drug products they take (both prescription and over-the-counter) may contain acetaminophen, making it entirely too easy to consume more than the recommended dosage of acetaminophen.

Acetaminophen Safety:

Do not take more than 4000 mg of acetaminophen per day.

Follow all drug labels as directed.

If you consume three or more alcoholic beverages every day try to avoid acetaminophen use.

If you are concerned that you may have ingested too much acetaminophen, please contact your doctor right away.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. The agency intends to address OTC acetaminophen products in a separate regulatory action.

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