Medication Guide App

Label Changes for:

Zyflo (zileuton) Tablets

June 2012

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

 

PRECAUTIONS

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