dexlansoprazole 60 MG Delayed Release Oral Capsule Dexilant
1 INDICATIONS AND USAGE DEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease DEXILANT is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Takeda Pharmaceuticals America, Inc.
CAPSULE BLUE TAP 60
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16 HOW SUPPLIED/STORAGE AND HANDLING DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with "TAP" and "30" imprinted on the capsule and supplied as: NDC Number Size 64764-171-11 Unit dose package of 100 64764-171-30 Bottle of 30 64764-171-90 Bottle of 90 64764-171-19 Bottle of 1000 DEXILANT delayed-release capsules, 60 mg, are opaque, blue with "TAP" and "60" imprinted on the capsule and supplied as: NDC Number Size 64764-175-11 Unit dose package of 100 64764-175-30 Bottle of 30 64764-175-90 Bottle of 90 64764-175-19 Bottle of 1000 Store 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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