Label: LACTULOSE liquid

  • NDC Code(s): 80432-068-33, 80432-068-35
  • Packager: TriRx Huntsville Pharmaceutical Services
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated December 10, 2024

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  • Description

    Description

  • Clinical Pharmacology

    Clinical Pharmacology

  • Indications and Usage

    Indications and Usage

  • Contraindications

    Contraindications

  • Warnings

    Warnings

  • Precautions

    Precautions

  • Pregnancy

    Pregnancy

  • Pediatric Use

    Pediatric Use

  • Adverse Reactions

    Adverse Reactions

  • Overdosage

    Overdosage

  • Dosage Administration

    Dosage and Administration

  • How Supplied

    How Supplied

  • Label 16 oz

    Label 16 oz

  • Label 32 oz

    Label 32 oz

  • INGREDIENTS AND APPEARANCE
    LACTULOSE 
    lactulose liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80432-068
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE10 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80432-068-33473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2024
    2NDC:80432-068-35946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07462312/10/2024
    Labeler - TriRx Huntsville Pharmaceutical Services (117090286)