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Label Changes for:

Potassium Chloride Extended Release Tablets, USP

June 2008

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

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 Summary of Changes to Contraindications and Warnings


  • Gastrointestinal Lesion


  • Information for Patients
    • Physicians should consider reminding the patient of the following...
  • Geriatric Use


Gastrointestinal Lesion

...Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract.

Label approved 06/13/2008 is not available on Drugs@FDA