Label: ULTRAMICROSIZE GRISEOFULVIN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 20, 2025

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  • DESCRIPTION
    Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of - Penicillium. Griseofulvin crystals are partly dissolved in ...
  • INDICATIONS
    Ultramicrosize griseofulvin tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea ...
  • CONTRAINDICATIONS
    This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Rare cases of conjoined twins have been ...
  • WARNINGS
    Prophylactic Usage:Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established. Since griseofulvin has demonstrated harmful effects - in vitroon the ...
  • PRECAUTIONS
    Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic, and hematopoietic, should be ...
  • ADVERSE REACTIONS
    When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes and urticaria, and rarely, angioneurotic edema and epidermal necrolysis (Lyell’s syndrome) ...
  • DOSAGE AND ADMINISTRATION
    Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium ...
  • HOW SUPPLIED
    Ultramicrosize Griseofulvin Tablets, USP 165 mg, off-white, oval shaped, scored tablets debossed with “ C” bisect “ E” on one side and “ 269” on the other side; bottle of 30 (NDC ...
  • PRINCIPAL DISPLAY PANEL
    Ultramicrosize Griseofulvin Tablets, USP 165 mg- NDC 62135-501-30 - 30s Tabs Bottle Label
  • INGREDIENTS AND APPEARANCE
    Product Information