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Label Changes for:


April 2009

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

  • Children’s Motrin (100 mg/5 mL ibuprofen) suspension [OTC]
  • Motrin IB (200 mg ibuprofen) tablets [OTC]
  • Motrin Infants’ Drops (50 mg/1.25 mL ibuprofen oral suspension) [OTC]
  • Motrin Junior Strength (100 mg ibuprofen) chewable tablets & Junior Strength Motrin (100 mg ibuprofen) tablets [OTC]

Label approved 04/24/2009 is not available on Drugs@FDA

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



  • 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"