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Butalbital and acetaminophen
HealthData.Gov
Updated Mar 25, 2026
About this dataset
Butalbital and Acetaminophen is a prescription oral tablet combining butalbital (a barbiturate for muscle relaxation) and acetaminophen (a pain reliever) to treat tension headaches. Available in strengths like 325mg acetaminophen with 50mg butalbital, it's a controlled substance (Schedule III) manufactured by Burel Pharmaceuticals, LLC under ANDA214088. This information was generated using AI and is provided for informational and research purposes only.
Data and resources (1)
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Butalbital and acetaminophen
Access the FDA dataset for Butalbital and acetaminophen — ANDA 203308 submitted by Mylan Institutional LLC
Modified Dec 27, 2025