Rx Item-Dexlansoprazole 30Mg Gen Dexilant Cap 30 By TWI Pharma

Clinical Information
Gen. Code and Des.
64793 dexlansoprazole ORAL CAP DR BP 30 MG
GCN and Des.
16305 dexlansoprazole ORAL CAP DR BP 30 MG
Strength
30MG DR
Dose Form
CAPSULE, DELAYED RELEASE, BIPHASIC
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
56283600 PROTON-PUMP INHIBITORS
Active Ingredients
12953 dexlansoprazole 138530946
Inactive Ingredients
10138 blue dye
10141 red dye
10143 yellow dye
7230 magnesium carbonate
2598 sucrose 57501

DEXILANT- dexlansoprazole capsule, delayed release
DEXILANT SOLUTAB- dexlansoprazole tablet, orally disintegrating, delayed release
Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis
? DEXILANT capsules are 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 capsules and DEXILANT SoluTab are 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 capsules and DEXILANT SoluTab are 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Patients 12 Years of Age and Older
? Two 30 mg DEXILANT SoluTab are not interchangeable with one 60 mg DEXILANT capsule [see Clinical Pharmacology (12.3)].

Dexlansoprazole 30Mg TWI
Item No.:RX753674 753674 NDC No.24979-0001-06 24979-001-06 24979000106 2497900106 UPC/GTIN No. 324979001067 3-24979-00106-7 324979=001067 MPN 900106

Dexlansoprazole 30Mg TWI
Item No.:RX753674 753674 NDC No.24979-0001-06 24979-001-06 24979000106 2497900106 UPC/GTIN No. 324979001067 3-24979-00106-7 324979=001067 MPN 900106

Dexlansoprazole 30Mg TWI
Item No.:RX753674 753674 NDC No.24979-0001-06 24979-001-06 24979000106 2497900106 UPC/GTIN No. 324979001067 3-24979-00106-7 324979=001067 MPN 900106

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RX ITEM-Dexilant 30Mg Cap 30 By Takeda P
NDC 64764-0171-30 UPC/GTIN No.3-64764-17130-8 Mfg.Part No.17130 TAP, 30 capsule , blue gray , oblong oblong Opaque

Dexilant 30mg Cap 30 by Takeda
BRAND: DEXILANT NDC: 64764-0171-30,64764017130 UPC: 3-64764-17130-8,364764171308 Takeda Pharma USA

DEXLANSOPRAZOLE ORAL CAP
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