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U.S. Department of Health and Human Services


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Advil Allergy Sinus Caplets (ibuprofen, pseudoephedrine HCl, chlorpheniramine maleate), 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

Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin...

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