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U.S. Department of Health and Human Services


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Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Caplets, Over-the-Counter

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008


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.

Summary View


Sections Modified Summary of Changes to Contraindications and Warnings


  • Ask a doctor before use if you have:
    • asthma (added)
  • Do not use:
    • in children under 12 years of age

For current prescribing information, contact Wyeth Consumer Healthcare at 1-800-882-3845.