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: â€¢ Treatment of active duodenal ulcer ( 1 ) â€¢ Treatment of active benign gastric ulcer ( 1 ) â€¢ Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) â€¢ Maintenance of healing of EE ( 1 )
dr.reddy's laboratories limited
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 â€˜00â€™ with opaque white colored body and cap respectively, imprinted with â€˜363â€™ on body and â€˜RDYâ€™ on cap, with blue ink containing white to off white powder, and are supplied in bottles of 30â€™s, 100â€™s and 500â€™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 â€˜00â€™ with opaque white colored body and opaque blue colored cap, imprinted â€˜364â€™ on body with blue ink and â€˜RDYâ€™ on cap, with white ink containing white to off white powder, and are supplied in bottles of 30â€™s, 100â€™s and 500â€™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 20Â°C to 25Â°C (68Â°F to 77Â°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.
dr.reddy's laboratories limited
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