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Label Changes for:


May 2009

Changes have been made to the WARNINGS sections of the safety label.

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

  • Advil (200 mg ibuprofen) tablets [OTC]
  • Advil Allergy Sinus (2mg clorpheniramine maleate, 200 mg ibuprofen, and 30 mg pseudoephedrine HCl) tablets [OTC]
  • Advil Cold & Sinus (200 mg ibuprofen and 30 mg pseudoephedrine HCl) tablets [OTC]
  • Advil Cold & Sinus Liqui-Gels (200 mg ibuprofen and 30 mg pseudoephedrine HCl) capsules [OTC]
  • Advil Liquigels (200 mg ibuprofen) capsules [OTC]
  • Advil PM (200 mg ibuprofen/ 38 mg diphenhydramine citrate)tablets [OTC]
  • Advil PM Liqui-Gels (200 mg ibuprofen/ 25 mg diphenhydramine HCl) capsules [OTC]
  • Children’s Advil (100 mg/ 5 mL ibuprofen) Suspension [OTC]
  • Children’s Advil Chewables (50 mg ibuprofen) chewable tablets [OTC]
  • Children’s Advil Cold (100 mg ibuprofen and 15mg/5ml pseudoephedrine HCl) suspension [OTC]
  • Infant's Advil drops (50 mg ibuprofen/ 1.25 mL) Concentrated Drops [OTC]
  • Junior Strength Advil (100 mg ibuprofen) tablets [OTC]
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.
Sections Modified

Summary of Changes to 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"