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U.S. Department of Health and Human Services

Safety

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Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (butalbital, acetaminophen, caffeine, and codeine Phosphate) Capsules


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

PRECAUTIONS

  • Ultra-rapid Metabolizers of Codeine

 

Label not available on Drugs@FDA