linagliptin 2.5 mg metformin 500 mg
1 INDICATIONS AND USAGE JENTADUETO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . JENTADUETO is a combination of linagliptin, 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 recommended in patients with type 1 diabetes mellitus ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2) ].
Boehringer Ingelheim Pharmaceuticals, Inc.
OVAL YELLOW D2 500
D2 500 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/500 mg are light yellow, oval, biconvex tablets debossed with "D2/500" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0146-60) Bottles of 180 (NDC 0597-0146-18) JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/850 mg are light orange, oval, biconvex tablets debossed with "D2/850" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0147-60) Bottles of 180 (NDC 0597-0147-18) JENTADUETO (linagliptin and metformin HCl) tablets 2.5 mg/1,000 mg are light pink, oval, biconvex tablets debossed with "D2/1000" on one side and the Boehringer Ingelheim symbol on the other side, and are supplied as follows: Bottles of 60 (NDC 0597-0148-60) Bottles of 180 (NDC 0597-0148-18) 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]. Protect from exposure to high humidity.
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