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OMNICEF (cefdinir) capsules, 300 mg and OMNICEF (cefdinir) oral suspension, 125 mg/5mL and 250 mg/5mL December 2008

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. Read about the new physician labeling format.


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...