Label: SINGLE-USE- docusate sodium enema

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 4, 2022

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  • DESCRIPTION

    Single-Use Enema

    For Use in dogs and cats

  • DOSAGE FORMS & STRENGTHS

    Each syringe contains a solution of dioctyl sodium sulfosuccinate (250 mg) in glycerine with sorbic acid as a preservative.

  • PRINCIPAL DISPLAY PANEL

    covetrus

    NDC:  11695-3202-1

    Single-use enema

    For use in dogs and cats

    Each syringe contains a solution of dioctyl sodium sulfosuccinate (250 mg) in glycerine with sorbic acid as a preservative.

    Reorder #002515

    12 mL (0.41 fl oz)

    Questions? (855) 724-3461

    Distributed by:

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    AH-002515-L-02

    Rev. 0619

  • PRINCIPAL DISPLAY PANEL

    Covetrus LabelCovetrus LabelCovetrus LabelCovetrus Label

  • INGREDIENTS AND APPEARANCE
    SINGLE-USE 
    docusate sodium enema
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-3202
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg  in 12 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-3202-112 in 1 CARTON
    112 mL in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - Covetrus (603750329)
    Registrant - Pegasus Laboratories, Inc (108454760)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pegasus Laboratories, Inc108454760manufacture, analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Cytec Industries Inc.013118166api manufacture