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What would be the new Acetaminophen strength in a reformulated Vicodin?
a. 500 mg
b. 300 mg
c. 325 mg
d. None of the above
Answer(b): 300 mg. On January 13, 2011, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per dosage unit.
The FDA has stated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing.
The FDA requested this change be effected by January 2014. Abbott, the manufacturer of Vicodin, has complied with this directive ahead of the FDA's requested date and has introduced new formulations of Vicodin (Hydrocodone bitartrate and Acetaminophen tablets, USP) with reduced acetaminophen content in the third quarter of 2012.
Vicodin is available in the following new formulations:
1. VICODIN® (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg
2. VICODIN ES® (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg
3. VICODIN HP® (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg
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