Label: PENTOBARBITAL SODIUM- euthanasia injection, solution

  • NDC Code(s): 11695-4862-5
  • Packager: Covetrus North America
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CII
  • 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 November 22, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Covetrus

    NDC:11695-4862-5

    Pentobarbital

    sodium Injection

    6 grains of pentobarbital sodium

    Euthanasia 

    FOR VETERNIARY EUTHANSIA ONLY

    CAUTION:Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

    Net contents: 250 mL

  • DOSAGE AND ADMINISTRATION

    Multiple dose Vial

    Dosage: For intravenous (preferred), intracardial, intrapleural or intraperitoneal injection.

    Small animals: 1 mL per 10 lb of body weight.

    Horses and other large animals: 1 mL per 10 lb of body weight, to a maximum dose of 100 mL.

    Each mL Contains:

    Pentobarbital Sodium...6 gr.

    Isopropyl Alcohol.........10%

    Propylene Glycol.........18%

    Benzyl Alcohol............2.0%

    Purified Water..............qs

    Green dye to establish a distinctive color.

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • WARNING

    This is a highly toxic parenteral solution specifically designed for rapid, painless and humane euthanasia of animals.

  • ENVIRONMENTAL HAZARD

    This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

  • WARNINGS AND PRECAUTIONS

    POISON

    Keep Out of Reach of Children

    For additional information about adverse drug experience reporting for animal contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth

    Questions?
    (855) 724 -3461

    Distributed by:
    Covetrus North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com

    AH-017285-L-01
    REV: 0919

  • PRINCIPAL DISPLAY PANEL

    Pentobarbital Sodium Inj Covetrus Label

  • INGREDIENTS AND APPEARANCE
    PENTOBARBITAL SODIUM 
    euthanasia injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-4862
    Route of AdministrationINTRAVENOUS, INTRACARDIAC, INTRAPLEURAL, INTRAPERITONEALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pentobarbital Sodium (UNII: NJJ0475N0S) (Pentobarbital - UNII:I4744080IR) Pentobarbital Sodium390 mg  in 1 mL
    Product Characteristics
    Colorgreen (Green dye to establish a distinctive color.) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-4862-5250 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/22/2019
    Labeler - Covetrus North America (603750329)