Potassium Chloride Extended Release Tablets, USP

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