VITAMIN B-12 5000 MCG- cyanocobalamin injection

Vitamin B-12 5000 mcg by

Drug Labeling and Warnings

Vitamin B-12 5000 mcg by is a Animal medication manufactured, distributed, or labeled by MWI/Vet One, Sparhawk Laboratories, Inc., Hebei Huarong Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS:

For use in managing Vitamin B12 deficiencies associated with cobalt deficiency, inadequate intake, or intestinal malabsorption in
cattle, sheep, swine, and horses.

EACH mL OF STERILE AQUEOUS SOLUTION CONTAINS:

Cyanocobalamin (Vitamin B12)..............5000 mcg

Benzyl Alcohol (preservative).................1.0% v/v

Sodium Chloride.................................0.22% w/v

Ammonium Sulfate...............................0.1% w/v

Citric Acid..........................................0.01% w/v

Sodium Citrate..................................0.008% w/v

DOSAGE & ADMINISTRATION:

Inject subcutaneously or intramuscularly. Dosage may be repeated at weekly intervals if necessary. May be injected intravenously at the discretion of the veterinarian.

Cattle and Horses ............................... 0.2 to 0.4 mL

Swine and Sheep .......................................... 0.1 mL

STORAGE:

Store at temperature between 15° and 30°C (59° - 86°F). Avoid exposure to light.

SPL UNCLASSIFIED SECTION

Rev. 08-17 

V-0430-04   L571-0904

TAKE TIME OBSERVE LABEL DIRECTIONS

SPL UNCLASSIFIED SECTION

Distributed by:
MWIBoise, ID 83705
www.VetOne.net
Manufactured by Sparhawk Laboratories,
Lenexa, KS 66215
for Neogen® Corporation
MADE IN USA

Principal Display Panel

INGREDIENTS AND APPEARANCE

VITAMIN B-12 5000 MCG 
cyanocobalamin injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-056
Route of Administration	INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
AMMONIUM SULFATE (UNII: SU46BAM238)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-056-85	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		09/01/2017

Labeler - MWI/Vet One (019926120)

Registrant - Sparhawk Laboratories, Inc. (147979082)

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

Establishment
Name	Address	ID/FEI	Business Operations
Hebei Huarong Pharmaceutical Co., Ltd.		529658734	api manufacture