ATROPINE SULFATE injection

Atropine Sulfate by

Drug Labeling and Warnings

Atropine Sulfate by is a Animal medication manufactured, distributed, or labeled by Covetrus North America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Covetrus

Atropine
sulfate injection

Injection 1/120 grain

Sterile, multiple-dose vial

For animal use only.

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

Net contents: 100 mL

For interveneous, intramuscular, or subcutaneous use

Composition: Each mL contains:
Atropine Sulfate  ............................  0.54 mg
Sodium Chloride .................................  9 mg
Benzyl Alcohol (preservative)...............  1.5%
Water for Injection  ...............................  q.s.
pH adjusted with sulfuric acid when necessary.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:
Dogs and cats:  Inject  1 mL for each 20 lbs. of body weight as a pre-anesthetic adjuvant or to reduce salivation, bronchial secretions or internal peristalsis associated with colic or diarrhea. 

As an antidote for parasympathomimetic drugs, 1 mL for each 7.5 lbs. of body weight.  It is suggested that 1/4 of the dosage be injected intravenous and the remainder intramuscular or subcutaneous.

WARNINGS

WARNING: Poisonous alkaloid.

Keep out of reach of children.

Antidotes:  warmth, emetics, cholinergics.

TAKE TIME OBSERVE LABEL DIRECTIONS

STORAGE AND HANDLING

Store at room temperature between 15° and 30°C (59°- 86°F)

Reorder #002452

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-024352-L-02
REV: 0919

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATROPINE SULFATE 
atropine sulfate injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4863
Route of Administration	INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.54 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4863-1	100 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)