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Label Changes for:

Prilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 2.5 mg and 10 mg

September 2012

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)


November 2012


Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules


October 2012



September 2012

  • Aciphex (rabeprazole sodium) Delayed-Release Tablets
  • Dexilant (dexlansoprazole) Delayed-Release Capsules
  • Prevacid (lansoprazole) Delayed-Release Capsules, and Delayed-Release Orally Disintegrating Tablets
  • Prilosec (omeprazole) Delayed-Release Capsules, Delayed-Release Oral Suspension
  • Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension