FDA may limit Acetaminophen max dosage to RX only

Current Situation

All acetaminophen, single-ingredient products are sold OTC.



The 325 mg per tablet or capsule would remain available OTC. Any formulation higher than that, such as 500 mg per tablet or capsule, would be available by prescription only. This option could be implemented in conjunction with option 6a, in which the recommended maximum OTC doses are reduced. With this option, products intended to deliver a maximum dose of 1000 mg (maximum daily dose 4 grams) would be made available Rx only.

Intended Effect

To allow higher doses of acetaminophen to remain available, but with a prescriber’s oversight. Considerations Related to Incidence of Hepatotoxicity (liver injury) • Added prescriber oversight via the Rx route could facilitate reducing the risk of acetaminophen overdose.

Considerations Related to Implementation

• Medical office visits required to obtain a prescription may entail additional monetary costs to consumers, such as copayments and potential mark-up costs by pharmacies, and treatment delays.

• Manufacturers would have to develop, submit, and have FDA review NDAs or ANDAs for new Rx products. Manufacturers would also have to address associated promotion and supply issues.

• Among those OTC products that have NDA or ANDA applications, the only single-ingredient tablet is a 650-mg, extended release version of acetaminophen. Most other candidate products are either suppositories or combination products that contain other ingredients such as caffeine or pseudoephedrine.Interested sponsors would need to file new NDA or ANDA applications.


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