Reference ID: 3675798 - Food and Drug Administration

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

ZEGERID safely and effectively. See full prescribing information for

ZEGERID.

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ZEGERID (omeprazole/sodium bicarbonate) powder for oral suspension

ZEGERID (omeprazole/sodium bicarbonate) capsules for oral use

Initial U.S. Approval: 2004

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¡ª¡ª¡ª¡ª¨C¡ª¡ª¡ª¡ª¡ªRECENT MAJOR CHANGES¡ª¡ª¡ª¡ª¡ª¡ª¡ª¡ª¨C

Warnings and Precautions, Acute Interstitial Nephritis (5.3)

12/2014

Warnings and Precautions, Cyanocobalamin

(Vitamin B-12) Deficiency (5.4)

12/2014

----------------------------INDICATIONS AND USAGE--------------------------ZEGERID is a proton pump inhibitor indicated for:

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Short-term treatment of active duodenal ulcer (1.1)

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Short-term treatment of active benign gastric ulcer (1.2)

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Treatment of gastroesophageal reflux disease (GERD) (1.3)

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Maintenance of healing of erosive esophagitis (1.4)

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Reduction of risk of upper GI bleeding in critically ill patients (1.5)

The safety and effectiveness of ZEGERID in pediatric patients ( ................
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