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Butalbital and acetaminophen

HealthData.Gov

Updated Oct 29, 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 214088 submitted by Mylan Institutional LLC

    Modified Jun 29, 2026

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