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U.S. Department of Health and Human Services

Safety

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Urex (methenamine hippurate) Tablets


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

PRECAUTIONS

  • General
    • Prescribing Urex in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
  • Information for Patients
    • Patients should be counseled that antibacterial drugs including Urex should only be used to treat bacterial infections...
  • Carcinogenesis, Mutagenesis, and Impairment of Fertility
    • Methenamine