Budesonide 3 MG Delayed Release Oral Capsule

1 INDICATIONS AND USAGE Budesonide delayed-release capsules (enteric coated) are 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 (enteric coated) 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 (enteric coated) 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.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] nausea` `[4] toxicity to various agents` `[5] completed suicide` `[6] off label use` `[7] fatigue` `[8] headache` `[9] pneumonia` `[10] diarrhoea`

2 years ago

CAPSULE ORANGE 720

16 HOW SUPPLIED/STORAGE AND HANDLING

BUDESONIDE Delayed-Release capsules (Enteric Coated) 3 mg are white to off-white, free flowing pellets, filled in size '1' hard gelatin capsules having opaque light-orange colored cap printed with "720" in black ink and opaque white body and are supplied as follows: NDC 68382-720-06 in bottle of 30 capsules with child-resistant closure NDC 68382-720-16 in bottle of 90 capsules with child-resistant closure NDC 68382-720-01 in bottle of 100 capsules with child-resistant closure NDC 68382-720-05 in bottle of 500 capsules NDC 68382-720-10 in bottle of 1,000 capsules NDC 68382-720-77 in unit-dose blister carton of 100 (10 x 10) unit-dose capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

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