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U.S. Department of Health and Human Services

Safety

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Zyflo (zileuton) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012

 

Summary View

 

PRECAUTIONS

Pediatric Use
  • Due to the risk of hepatoxicity, use of Zyflo in pediatric patients under 12 years is not recommended