Oral Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit

FDA continues to receive reports of severe liver injury associated with the use of acetaminophen-containing products. The greatest risk for severe liver injury happens when people take more than the prescribed dose of acetaminophen, take more than one acetaminophen-containing product at the same time, or drink alcohol while taking acetaminophen. Severe liver injury can lead to liver failure, liver transplant, and death.


By limiting the maximum amount of acetaminophen in oral prescription products to 325 mg per tablet, capsule, or other dosage unit, patients will be less likely to overdose on acetaminophen if they mistakenly take too many doses of acetaminophen-containing products.

Many oral prescription combination acetaminophen products are currently available in multiple strengths, including 325 mg, in the United States. Some of these products contain up to 750 mg of acetaminophen per tablet, capsule, or other dosage unit. To comply with the new requirement, companies that market oral drug products containing higher strengths of acetaminophen will need to limit the amount of acetaminophen to 325 mg per dosage unit or they may choose to withdraw the drug products.

For example, if a healthcare professional previously prescribed 1 or 2 tablets of an oral prescription acetaminophen combination product every 4 to 6 hours, these dosing instructions will not change. A prescription drug containing 325 mg of acetaminophen prescribed at a maximum dosage of 2 tablets every 4 hours will add up to a total daily dose of 3900 mg (3.9 grams), which is less than the 4000 mg recommended maximum daily dose of acetaminophen.

OTC acetaminophen products such as Tylenol are not affected by the new 325 mg limit at this time.


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