PENTOBARBITAL SODIUM- euthanasia injection, solution

Drug Labeling and Warnings

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PENTOBARBITAL SODIUM 
euthanasia injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4862
Route of Administration	INTRAVENOUS, INTRACARDIAC, INTRAPLEURAL, INTRAPERITONEAL	DEA Schedule	CII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pentobarbital Sodium (UNII: NJJ0475N0S) (Pentobarbital - UNII:I4744080IR)	Pentobarbital Sodium	390 mg  in 1 mL

Product Characteristics
Color	green (Green dye to establish a distinctive color.)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4862-5	250 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/22/2019

Labeler - Covetrus North America (603750329)