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U.S. Department of Health and Human Services


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Resources for You

Hycodan (hydrocodone and homatropine) Tablets January 2009

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


  • Respiratory Depression
  • Pediatric Use


  • Information for Patients
  • Pediatric Use


  • Respiratory Depression


  • Respiratory Depression
    • ...not recommended for use in children less than 6 years of age because...
  • Pediatric use
    • Caution should be exercised when administering Hycodan to pediatric patients 6 years of age and older because...