donepezil hydrochloride tablet film coated
1 INDICATIONS AND USAGE Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride tablets are acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease ( 1 )
Jubilant Cadista Pharmaceuticals Inc.
ROUND WHITE J 5
J 5 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Donepezil Hydrochloride Tablets, USP Supplied as white to off-white, round, film-coated tablets containing either 5 mg or 10 mg of donepezil hydrochloride, USP. The 5 mg tablets are white to off-white, round, film-coated tablets, debossed with ‘J’ on one side and ‘5’ on the other side. Bottles of 30 (child-resistant) NDC 59746-329-30 Bottles of 90 (child-resistant) NDC 59746-329-90 Bottles of 100 (child-resistant) NDC 59746-329-01 Bottles of 500 NDC 59746-329-05 Bottles of 1000 NDC 59746-329-10 10 x 10 Unit-dose Tablets NDC 59746-329-03 The 10 mg tablets are white to off-white, round, film-coated tablets, debossed with ‘J’ on one side and ‘10’ on the other side. Bottles of 30 (child-resistant) NDC 59746-330-30 Bottles of 90 (child-resistant) NDC 59746-330-90 Bottles of 100 (child-resistant) NDC 59746-330-01 Bottles of 500 NDC 59746-330-05 Bottles of 1000 NDC 59746-330-10 10 x 10 Unit-dose Tablets NDC 59746-330-03 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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