Label Changes for:
Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol
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)
USE IN SPECIFIC POPULATIONS
- Pediatric Use section updated
Postmarketing Adverse Reactions
- added ... dysphonia and gastroesophageal reflux disease