Label Changes for:

Sodium Iodide I-131 Therapeutic Capsules and Therapeutic Solution

February 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

ADVERSE REACTIONS

  • Published reports have described salivary and lacrimal gland dysfunction.
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