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U.S. Department of Health and Human Services

Safety

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Ventolin HFA (albuterol sulfate) Inhalation Aerosol

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

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

 

September 2012

Summary View

6 ADVERSE REACTIONS

6.2 Post-Market Experience
  • metabolic acidosis added

 

March 2008

Summary View

Sections Modified

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
  • Table 2

 

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