Label: HYDROCHLOROTHIAZIDE tablet

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

Drug Label Information

Updated January 8, 2025

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  • DESCRIPTION
    Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 - H-1,2,4-benzothiadiazine-7-sulfonamide ...
  • CLINICAL PHARMACOLOGY
    The mechanism of the antihypertensive effect of thiazides is unknown. Hydrochlorothiazide does not usually affect normal blood pressure. Hydrochlorothiazide affects the distal renal tubular ...
  • INDICATIONS AND USAGE
    Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated  with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide ...
  • CONTRAINDICATIONS
    Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.
  • WARNINGS
    Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with imparied renal ...
  • PRECAUTIONS
    General - All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and ...
  • Information for Patients
    Non-melanoma Skin Cancer:Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. Repackaged By / Distributed By: RemedyRepack ...
  • ADVERSE REACTIONS
    The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole:Weakness. Cardiovascular:Hypotension including ...
  • DOSAGE AND ADMINISTRATION
    Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response. Adults - For Edema - The usual adult dosage is 25 to 100 mg ...
  • OVERDOSAGE
    The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis ...
  • HOW SUPPLIED
    Hydrochlorothiazide Tablets USP, 12.5 mg are peach colored, round, debossed "A" one side and "1" on the other side. Hydrochlorothiazide Tablets USP, 12.5 mg are supplied as follows: NDC ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: HYDROCHLOROTHIAZIDE - GENERIC: hydrochlorothiazide - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-4251-0 - COLOR: orange - SHAPE: ROUND - SCORE: No score - SIZE: 6 mm - IMPRINT: A;1 - PACKAGING: 90 in 1 ...
  • INGREDIENTS AND APPEARANCE
    Product Information