Furosemide 40 MG Oral Tablet
INDICATIONS AND USAGE Edema Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
Roxane Laboratories, Inc
ROUND WHITE 54 583
54 583 ROUND WHITE
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HOW SUPPLIED
FUROSEMIDE Tablets, USP 20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54 840” debossed on one side. NDC 0054-8297-25: Unit-Dose (10 x 10) NDC 0054-4297-25: Bottle of 100 Tablets NDC 0054-4297-31: Bottle of 1000 Tablets 40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 583” debossed on one side. NDC 0054-8299-25: Unit-Dose (10 x 10) NDC 0054-4299-25: Bottle of 100 Tablets NDC 0054-4299-31: Bottle of 1000 Tablets 80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 533” debossed on one side. NDC 0054-8301-25: Unit-Dose (10 x 10) NDC 0054-4301-25: Bottle of 100 Tablets NDC 0054-4301-29: Bottle of 500 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Note: Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Protect From Moisture. PROTECT FROM LIGHT.
FUROSEMIDE Oral Solution, USP 10 mg per mL oral solution is supplied as a (orange-flavored) clear, orange-colored solution. NDC 0054-3294-46: Bottle of 60 mL Dispense only in this bottle and only with the calibrated oral syringe provided. NDC 0054-3294-50: Bottle of 120 mL Dispense only in this bottle. PROTECT FROM LIGHT. NOTE: DISCARD OPENED BOTTLE AFTER 90 DAYS. 40 mg per 5 mL oral solution is supplied as a (pineapple-peach flavored) clear, orange-colored solution. NDC 0054-3298-63: Bottle of 500 mL Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF PROTECT FROM LIGHT. Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000360/01 Revised October 2023
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