Label Changes for:

Children’s Advil Chewables (50 ibuprofen) Chewable Tablets

June 2008

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) -- 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

WARNINGS

  • Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

  • Information for Patients
    • …Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued...

WARNINGS

Ask a doctor before use if the child has:

  • asthma (added)

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

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