Budesonide 3 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Budesonide delayed-release capsules are a corticosteroid indicated for: Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. (1.1) Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. (1.2) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.
Amneal Pharmaceuticals LLC
CAPSULE RED AMNEAL 778
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUDESONIDE delayed-release capsules, 3 mg, are supplied as hard gelatin capsules with an opaque light gray body imprinted “778” and an opaque maroon cap imprinted “AMNEAL” with black ink. They are available as follows: Bottles of 21: NDC 65162-778-49 Bottles of 100: NDC 65162-778-10 Bottles of 180: NDC 65162-778-18 Bottles of 300: NDC 65162-778-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
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