Label Changes for:

Hycodan (hydrocodone and homatropine) Tablets

January 2009

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

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.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Respiratory Depression
  • Pediatric Use

PRECAUTIONS

  • Information for Patients
  • Pediatric Use

ADVERSE REACTIONS

  • Respiratory Depression

WARNINGS

  • 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...
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