Pantoprazole Sodium 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 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 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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 erosive esophagitis 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 syndrome.
Aphena Pharma Solutions - Tennessee, LLC
OVAL YELLOW P 40
P 40 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. How Supplied Pantoprazole Sodium Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with P40 (brown ink) on one side and are available as follows: NDC 0008-0607-01 bottles of 90 tablets NDC 0008-0607-04 cartons of 10 Redipak ® blister strips of 10 tablets Pantoprazole Sodium Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side and are available as follows: NDC 0008-0606-01 bottles of 90 tablets Storage Store Pantoprazole Sodium Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature ] .
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