pantoprazole sodium delayedrelease 40 mg
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 is 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
lifestar pharma llc
ROUND BROWN L9
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16 HOW SUPPLIED/STORAGE AND HANDLING
PANTOPRAZOLE SODIUM DELAYED-RELEASE Tablets, USP are supplied as light brown to brown, round, biconvex, delayed-release tablets imprinted with 'L9' on one side and plain on other side containing 40 mg pantoprazole and are available as follows: NDC 70756-019-90, bottles of 90, with child-resistant closure. NDC 70756-019-12, bottles of 1000, this package is not child resistant.
PANTOPRAZOLE SODIUM DELAYED-RELEASE Tablets USP are supplied as light brown to brown, round, biconvex, delayed-release tablets imprinted with 'L8' on one side and plain on other side containing 20 mg pantoprazole and are available as follows: NDC 70756-018-90, bottles of 90, with child-resistant closure. NDC 70756-018-51, bottles of 500, this package is not child resistant. Storage Store
PANTOPRAZOLE SODIUM DELAYED-RELEASE tablets at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.]
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