Label: CHOLESTYRAMINE LIGHT- cholestyramine powder, for suspension

  • NDC Code(s): 51224-009-10, 51224-009-20
  • Packager: TAGI Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 17, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Cholestyramine for oral suspension USP, light, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite ...
  • CLINICAL PHARMACOLOGY
    Cholesterol is probably the sole precursor of bile acids. During normal digestion, bile acids are secreted into the intestines. A major portion of the bile acids is absorbed from the intestinal ...
  • INDICATIONS AND USAGE
    1) Cholestyramine for oral suspension USP, light is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated ...
  • CONTRAINDICATIONS
    Cholestyramine for oral suspension USP, light is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown ...
  • WARNINGS
    PHENYLKETONURICS - CHOLESTYRAMINE FOR ORAL SUSPENSION USP, LIGHT CONTAINS 16.8 mg PHENYLALANINE PER 4.8 GRAM DOSE.
  • PRECAUTIONS
    General - Chronic use of cholestyramine resin may be associated with increased bleeding tendency due to hypoprothrombinemia associated with Vitamin K deficiency. This will usually respond ...
  • ADVERSE REACTIONS
    The most common adverse reaction is constipation. When used as a cholesterol-lowering agent predisposing factors for most complaints of constipation are high dose and increased age (more than 60 ...
  • OVERDOSAGE
    Overdosage of cholestyramine resin has been reported in a patient taking 150% of the maximum recommended daily dosage for a period of several weeks. No ill effects were reported. Should an ...
  • DOSAGE AND ADMINISTRATION
    The recommended starting adult dose for cholestyramine for oral suspension USP, light is one pouch or one level scoopful (4.8 grams of cholestyramine for oral suspension USP, light contains 4 ...
  • HOW SUPPLIED
    Cholestyramine for oral suspension USP, light orange flavor is available in a carton of 60 single-dose 4.8 gram pouches and in a can containing 201.6 grams. Each 4.8 gram dose of cholestyramine ...
  • REFERENCES
    1. The Lipid Research Clinics Coronary Primary Prevention Trial Results: (I) Reduction in Incidence of Coronary Heart Disease; (II) The Relationship of Reduction in Incidence of Coronary Heart ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for - TAGI Pharma, Inc. South Beloit, IL 61080 - Manufactured by - Laboratorios Rubió, S.A. Industria, 29, Pol. Ind. Comte de Sert - 08755-Castellbisbal (Barcelona) Spain - 36126005 0120 - Rev ...
  • PRINCIPAL DISPLAY PANEL - 4 gram Pouch Carton
    60 Single-Dose Pouches - NDC 51224-009-20 - Cholestyramine for Oral - Suspension USP, Light - Powder - 4 grams cholestyramine resin USP, per pouch* *each pouch contains 4 grams cholestyramine resin ...
  • INGREDIENTS AND APPEARANCE
    Product Information