Skip to Content

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


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.