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FDA Acetaminophen Information

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FDA Acetaminophen Information

Post  Admin on Thu Aug 04, 2011 11:46 pm

FDA Acetaminophen Information

On January 13, 2011, FDA announced that it is asking manufacturers of prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit. FDA believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death.




Under the leadership of the National Council for Prescription Drug Programs (NCPDP), FDA’s Safe Use Initiative and a broad group of stakeholders came together to form the Acetaminophen Best Practices Task Group, which produced the white paper.

The White Paper recommends:
* complete spelling of acetaminophen and all other active ingredients on the pharmacy labels of all acetaminophen-containing prescription medicine, eliminating the use of abbreviations, acronyms or other shortened versions for active ingredients
* a standardized concomitant use and liver pharmacy warning label for these medicines
* formatting and wording on pharmacy container labels consistent with plain language and health literacy principles
* a stakeholder call to action: adopt, implement, adhere, communicate and educate



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