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

WARNINGS

  • Gastrointestinal Lesion

PRECAUTIONS

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

WARNINGS

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

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