EPINEPHRINE- epinephrine injection

Drug Labeling and Warnings

Drug Details [pdf]

EPINEPHRINE INJECTION

1 mg/mL

STERILE MULTIPLE DOSE VIAL

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS

For emergency use only in treating anaphylactoid shock in sheep, swine, cattle, horses, dogs and cats.

DOSAGE AND ADMINISTRATION

Dogs and Cats: 0.1 to 0.5 mL injected Intramuscularly or Subcutaneously.

Cattle, Horses, Sheep and Swine: 1 mL per 100 lbs of body weight injected Intramuscularly or Subcutaneously.

WARNING

Do not use this product if it's color is pinkish or darker than slightly yellow or if it contains a precipitate.

COMPOSITION

Each mL of sterile aqueous solution contains:

Epinephrine ....................... 1 mg

Sodium Chloride ................  0.1%

Benzyl Alcohol ..................  1.5%

Disodium Edetate, Sodium Metabisulfite, Hydrochloric Acid, and Water for Injection.

STORAGE AND HANDLING

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

Protect from light.

TAKE TIME OBSERVE LABEL DIRECTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPINEPHRINE  
epinephrine injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 46066-940
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-940-02	50 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/22/2020

Labeler - Aspen Veterinary Resources®, LTD. (627265361)

Registrant - Sparhawk Laboratories, Inc (147979082)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc		147979082	manufacture, analysis

Establishment
Name	Address	ID/FEI	Business Operations
SYN-TECH CHEM. & PHARM. CO., LTD.		656002532	api manufacture