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Label Changes for:

OMNICEF (cefdinir) capsules, 300 mg and OMNICEF (cefdinir) oral suspension, 125 mg/5mL and 250 mg/5mL

December 2008

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

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



  • Post-Marketing Experience


  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including OMNICEF, and...