24 HR Metformin hydrochloride 1000 MG sitagliptin 100 MG Extended Release Oral Tablet Janumet
1 INDICATIONS AND USAGE JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not for the treatment of type 1 diabetes. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ) Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR. [See Warnings and Precautions (5.2) .]
Merck Sharp & Dohme Corp.
OVAL BLUE 81
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets supplied as follows: Contents Description How Supplied NDC 50 mg sitagliptin and 500 mg metformin HCl extended-release light blue, bi-convex oval, film-coated tablets with “78” debossed on one side unit-of-use bottles of 60 NDC 0006-0078-61 unit-of-use bottles of 180 NDC 0006-0078-62 bulk bottles of 1000 NDC 0006-0078-82 50 mg sitagliptin and 1000 mg metformin HCl extended-release light green, bi-convex oval, film-coated tablets with “80” debossed on one side unit-of-use bottles of 60 NDC 0006-0080-61 unit-of-use bottles of 180 NDC 0006-0080-62 bulk bottles of 1000 NDC 0006-0080-82 100 mg sitagliptin and 1000 mg metformin HCl extended-release blue, bi-convex oval, film-coated tablets with “81” debossed on one side unit-of-use bottles of 30 NDC 0006-0081-31 unit-of-use bottles of 90 NDC 0006-0081-54 bulk bottles of 1000 NDC 0006-0081-82 Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed. When container is subdivided, dispense into a USP tightly closed, moisture-resistant container.
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