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FDA Limits Acetaminophen in Prescription Drugs

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FDA Limits Acetaminophen in Prescription Drugs

The FDA is limiting the amount of acetaminophen that can be used in prescription

painkillers to 325 mg per dose.

The agency is also requiring a boxed warning highlighting the risk for severe

liver injury associated with prescription drugs containing acetaminophen (e.g.,

Vicodin, Lortab, Tylox, Percocet). The drugs' labels will also carry a warning

about the risk for allergic reaction.

The FDA asks clinicians to caution patients not to exceed 4 grams of

acetaminophen daily and not to drink alcohol when using acetaminophen products.

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