dexlansoprazole 30 mg
1 INDICATIONS AND USAGE Dexlansoprazole delayed-release capsules are 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 Dexlansoprazole delayed-release 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 Dexlansoprazole delayed-release capsules 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 Dexlansoprazole delayed-release capsules 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.
mylan pharmaceuticals inc.
CAPSULE BLUE Mylan DX 30
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dexlansoprazole 60 mg
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEXLANSOPRAZOLE Delayed-Release capsules are available containing 30 mg or 60 mg of
DEXLANSOPRAZOLE sesquihydrate as enteric-coated pellets. The 30 mg capsules are cellulose capsules with a light blue opaque cap and white opaque body filled with creamish yellow to brownish yellow pellets. The capsules are axially printed with MYLAN over DX 30 in black ink on cap and body. They are available as follows: NDC 0378-2085-93 bottles of 30 capsules NDC 0378-2085-77 bottles of 90 capsules NDC 0378-2085-05 bottles of 500 capsules The 60 mg capsules are cellulose capsules with a light blue opaque cap and light blue opaque body filled with creamish yellow to brownish yellow pellets. The capsules are axially printed with MYLAN over DX 60 in black ink on cap and body. They are available as follows: NDC 0378-2086-93 bottles of 30 capsules NDC 0378-2086-77 bottles of 90 capsules NDC 0378-2086-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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