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Label Changes for:

Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP)

February 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

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


  • Information for Patients
    • Breastfeeding
      • Methadone use is usually compatible with breastfeeding. Pregnant
        mothers using methadone should be counseled about the benefits and risks of breastfeeding while using methadone...