pantoprazole 40 MG Delayed Release Oral Tablet
1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) Maintenance of Healing of Erosive Esophagitis ( 1.2 ) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Dr.Reddy's Laboratories Limited
ROUND YELLOW R333
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
PANTOPRAZOLE sodium delayed-release tablets USP 20 mg are yellow, round, biconvex coated tablets printed with “R332” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30 NDC 55111-332-30 Bottles of 90 NDC 55111-332-90 Bottles of 100 NDC 55111-332-01 Bottles of 500 NDC 55111-332-05 Bottles of 1000 NDC 55111-332-10 Unit dose package of 30 (3 x 10) NDC 55111-332-81 Unit dose package of 100 (10 x 10) NDC 55111-332-78
PANTOPRAZOLE sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30 NDC 55111-333-30 Bottles of 90 NDC 55111-333-90 Bottles of 100 NDC 55111-333-01 Bottles of 500 NDC 55111-333-05 Bottles of 1000 NDC 55111-333-10 Unit dose package of 30 (3 x 10) NDC 55111-333-81 Unit dose package of 100 (10 x 10) NDC 55111-333-78 Storage Store
PANTOPRAZOLE sodium delayed-release tablets, USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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