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U.S. Department of Health and Human Services

Safety

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Aleve (220 mg naproxen sodium) caplet, tablet, and gelcap [OTC]

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings
WARNINGS

WARNINGS

 

  • Revised cardiovascular warning
    • "When using this product the risk of heart attack or stroke may increase if you use more than directed or for longer than directed"
  • Addition of the warning statement
    • "Ask a doctor before use if you have asthma"

 

 
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