Label: HYDROCHLOROTHIAZIDE capsule, gelatin coated

  • NDC Code(s): 0591-0347-01, 0591-0347-05
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated August 1, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its ...
  • CLINICAL PHARMACOLOGY
    Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of ...
  • INDICATIONS AND USAGE
    Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination ...
  • CONTRAINDICATIONS
    Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
  • WARNINGS
    Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma ...
  • PRECAUTIONS
    Electrolyte and Fluid Balance Status: In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of hydrochlorothiazide than in ...
  • ADVERSE REACTIONS
    The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide ...
  • 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 has ...
  • DOSAGE AND ADMINISTRATION
    For Control of Hypertension: The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses ...
  • HOW SUPPLIED
    Hydrochlorothiazide Capsules, USP are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. They are supplied in bottles of 100 (NDC ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-0347-01 - Hydrochlorothiazide Capsules, USP - 12.5 mg - Rx only - 100 Capsules - teva
  • INGREDIENTS AND APPEARANCE
    Product Information