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U.S. Department of Health and Human Services


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Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension) June 2008

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


  • General
    • A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
    • Drug Interactions
      • ...reduced efficacy of combined oral estrogen/progesterone contraceptives.


  • Infections and Infestations
    • Mucocutaneous Candidiasis
  • Gastrointestinal
    • Black Hairy Tongue
  • Hypersensitivity Reactions
    • Anaphylaxis (See WARNINGS)