Modified 24 HR Metformin hydrochloride 1000 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use Metformin hydrochloride extended-release tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Important limitations of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
Actavis Pharma, Inc.
ROUND WHITE WPI 1000
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Modified 24 HR Metformin hydrochloride 500 MG Extended Release Oral Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING
METFORMIN HYDROCHLORIDE extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 500 ” on the bottom of one side, and plain on the other.
METFORMIN HYDROCHLORIDE extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 1000 ” on the bottom of one side, and plain on the other. They are supplied as follows: Package Strength NDC Code Bottles of 30 500 mg 0591-2411-30 Bottles of 100 500 mg 0591-2411-01 Bottles of 1,000 500 mg 0591-2411-10 Bottles of 30 1,000 mg 0591-2412-30 Bottles of 90 1,000 mg 0591-2412-19 Bottles of 1,000 1,000 mg 0591-2412-10 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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