Label: FUROSEMIDE tablet

  • NDC Code(s): 83980-002-01, 83980-002-10, 83980-002-97, 83980-003-01, view more
  • Packager: Ipca Laboratories Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 19, 2024

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  • SPL UNCLASSIFIED SECTION
    WARNING - Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is ...
  • DESCRIPTION
    Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ...
  • CLINICAL PHARMACOLOGY
    Investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental ...
  • INDICATIONS AND USAGE
    Edema - Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease ...
  • CONTRAINDICATIONS
    Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
  • WARNINGS
    In patients with hepatic cirrhosis and ascites, furosemide tablets therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be ...
  • PRECAUTIONS
    General - Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. As with ...
  • ADVERSE REACTIONS
    Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions - hepatic encephalopathy in patients with hepatocellular ...
  • OVERDOSAGE
    The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are ...
  • DOSAGE AND ADMINISTRATION
    Edema - Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Adults -- The ...
  • HOW SUPPLIED
    Furosemide tablets, USP 20 mg, 40 mg and 80 mg are supplied as white to off-white, round tablets. 40 mg tablets and 80 mg tablets have functional scoring. Furosemide tablets, USP 20 mg are ...
  • SPL UNCLASSIFIED SECTION
    Distributed by: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, USA - July 2024 - IBZZN4
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 83980-002-01 - Furosemide Tablets, USP - 20 mg - Rx Only - 100 Tablets - NDC 83980-003-01 - Furosemide Tablets, USP - 40 mg - Rx Only - 100 Tablets - NDC 83980-004-01 - Furosemide ...
  • INGREDIENTS AND APPEARANCE
    Product Information