Label Changes for:

EC-Naprosyn (naproxen delayed-release tablets)

March 2013

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

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

 

March 2013

WARNINGS

Renal Effects
  • Patients at greatest risk of this reaction are those taking………..or angiotensin receptor blockers (ARBs),
Advanced Renal Disease
  •  ...and patients should be adequately hydrated.
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