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Omeprazole 20 MG Sodium Bicarbonate 1100 MG Oral Capsule

1 INDICATIONS AND USAGE Omeprazole and sodium bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may be considered. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. Omeprazole and sodium bicarbonate capsules are proton pump inhibitor (PPI). Omeprazole and sodium bicarbonate capsules are indicated in adults for: • Treatment of active duodenal ulcer ( 1 ) • Treatment of active benign gastric ulcer ( 1 ) • Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) • Maintenance of healing of EE ( 1 )

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1 year ago CAPSULE WHITE RDY 363 Omeprazole 20 MG  Sodium Bicarbonate 1100 MG Oral Capsule

CAPSULE WHITE RDY 363

16 HOW SUPPLIED/STORAGE AND HANDLING Omeprazole and sodium bicarbonate capsules, USP are supplied as: Omeprazole and Sodium Bicarbonate Capsules, USP 20 mg/1100 mg: Hard gelatin capsule size ‘00’ with opaque white colored body and cap respectively, imprinted with ‘363’ on body and ‘RDY’ on cap, with blue ink containing white to off white powder, and are supplied in bottles of 30’s, 100’s and 500’s. Bottles of 30 NDC 55111-363-30 Bottles of 100 NDC 55111-363-01 Bottles of 500 NDC 55111-363-05 Omeprazole and Sodium Bicarbonate Capsules, USP 40 mg/1100 mg: Hard gelatin capsule size ‘00’ with opaque white colored body and opaque blue colored cap, imprinted ‘364’ on body with blue ink and ‘RDY’ on cap, with white ink containing white to off white powder, and are supplied in bottles of 30’s, 100’s and 500’s. Bottles of 30 NDC 55111-364-30 Bottles of 100 NDC 55111-364-01 Bottles of 500 NDC 55111-364-05 Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

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