Label: CARAFATE- sucralfate 1gm tablet

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

Drug Label Information

Updated November 16, 2020

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  • Dosage and Administration Section

    DOSAGE AND ADMINISTRATION

    Active Duodenal Ulcer

    The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.

    Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

    While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

    Maintenance Therapy

    The recommended adult oral dosage is 1 g twice a day.

    Elderly

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS, Geriatric Use).

    Call your doctor for medical advice about side effects. You may report side effects to TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • Indications and Usage Section

    INDICATIONS AND USAGE

    Sucralfate tablets, USP are indicated in:

    Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
    Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

  • Principal Display Panel

    Sucralfate 1gm

  • INGREDIENTS AND APPEARANCE
    CARAFATE 
    sucralfate 1gm tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0091(NDC:0093-2210)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5) SUCRALFATE1 g
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code TEVA;22;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0091-130 in 1 BOTTLE; Type 0: Not a Combination Product11/11/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07084811/11/1996
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0091)