galantamine hydrobromide 8 mg
1 INDICATIONS AND USAGE Galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine extended-release capsules are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. ( 1 )
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Galantamine Extended-Release capsules, USP are available containing galantamine hydrobromide, USP equivalent to 8 mg, 16 mg or 24 mg of galantamine, respectively. The 8 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and a white opaque body filled with one round, unscored, uncoated white tablet with no markings. The capsule is axially printed with MYLAN over GT 8 in black ink on both the cap and body. They are available as follows: NDC 0378-8105-93 bottles of 30 capsules The 16 mg capsule is a hard-shell gelatin capsule with a pale pink opaque cap and a white opaque body filled with two round, unscored, uncoated white tablets with no markings. The capsule is axially printed with MYLAN over GT 16 in black ink on both the cap and body. They are available as follows: NDC 0378-8106-93 bottles of 30 capsules The 24 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and a white opaque body filled with three round, unscored, uncoated white tablets with no markings. The capsule is axially printed with MYLAN over GT 24 in black ink on both the cap and body. They are available as follows: NDC 0378-8107-93 bottles of 30 capsules 16.2 Storage and Handling 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. Keep out of reach of children.
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