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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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONRx only
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DESCRIPTIONCholestyramine 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 ...
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CLINICAL PHARMACOLOGYCholesterol 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 ...
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INDICATIONS AND USAGE1) 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 ...
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CONTRAINDICATIONSCholestyramine 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 ...
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WARNINGSPHENYLKETONURICS - CHOLESTYRAMINE FOR ORAL SUSPENSION USP, LIGHT CONTAINS 16.8 mg PHENYLALANINE PER 4.8 GRAM DOSE.
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PRECAUTIONSGeneral - Chronic use of cholestyramine resin may be associated with increased bleeding tendency due to hypoprothrombinemia associated with Vitamin K deficiency. This will usually respond ...
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ADVERSE REACTIONSThe 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 ...
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OVERDOSAGEOverdosage 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 ...
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DOSAGE AND ADMINISTRATIONThe 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 ...
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HOW SUPPLIEDCholestyramine 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 ...
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REFERENCES1. 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 ...
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SPL UNCLASSIFIED SECTIONManufactured 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 ...
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PRINCIPAL DISPLAY PANEL - 4 gram Pouch Carton60 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 ...
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INGREDIENTS AND APPEARANCEProduct Information