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Label Changes for:

Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol

March 2015

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)

March 2015

USE IN SPECIFIC POPULATIONS

  • Pediatric Use section updated

 

September 2013

ADVERSE REACTIONS

Postmarketing Adverse Reactions
  • added ... dysphonia and gastroesophageal reflux disease
     

 

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