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U.S. Department of Health and Human Services

Safety

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Esomeprazole and Omeprazole Products

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

Nexium I.V. (esomeprazole sodium) for Intravenous Injection
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension
Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets
Prilosec (omeprazole) Delayed-Release Capsules
Prilosec (omeprazole magnesium) Delayed-Release Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules

 

February 2014

Summary View

8 USE IN SPECIFIC POPULATION

8.1 Pregnancy
  • entire section revised
8.4 Pediatric use
  • entire section revised