carvedilol 3.125 MG Oral Tablet
1 INDICATIONS AND USAGE Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.2 ) hypertension( 1.3 ) 1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions ( 7.4 ), Clinical Studies ( 14.1 )] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2 )] . 1.3 Hypertension Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies ( 14.3 , 14.4 )] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2 )] .
Zydus Pharmaceuticals (USA) Inc.
ROUND WHITE Z 1
Z 1 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
CARVEDILOL Tablets USP, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with 'Z' on one side and '1' on other side and are supplied as follows: NDC-68382-092-17 in bottles of 28 tablets with child-resistant closure NDC-68382-092-01 in bottles of 100 tablets NDC-68382-092-05 in bottles of 500 tablets
CARVEDILOL Tablets USP, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC40' on one side and plain on other side and are supplied as follows: NDC-68382-093-17 in bottles of 28 tablets with child-resistant closure NDC-68382-093-01 in bottles of 100 tablets NDC-68382-093-05 in bottles of 500 tablets
CARVEDILOL Tablets USP, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC41' on one side and plain on other side and are supplied as follows: NDC-68382-094-17 in bottles of 28 tablets with child-resistant closure NDC-68382-094-01 in bottles of 100 tablets NDC-68382-094-05 in bottles of 500 tablets
CARVEDILOL Tablets USP, 25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC42' on one side and plain on other side and are supplied as follows: NDC-68382-095-17 in bottles of 28 tablets with child-resistant closure NDC-68382-095-01 in bottles of 100 tablets NDC-68382-095-05 in bottles of 500 tablets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
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