Pentobarbital Sodium: Product Information

PENTOBARBITAL SODIUM- pentobarbital sodium injection, solution
Covetrus North America

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.

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.

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 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 (Pentobarbital) 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 Multilevel Packaging 1 NDC:11695-4862-5 250 mL in 1 VIAL, MULTI-DOSE None

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)

Revised: 11/2019 Covetrus North America