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

