FORTIFIED VITAMIN B COMPLEX- cyanocobalamin niacinamide depanthenol pyridoxine hydrochloride thiamine hydrochloride riboflavin 5 phosphate sodium injection

Fortified Vitamin B Complex by

Drug Labeling and Warnings

Fortified Vitamin B Complex by is a Animal medication manufactured, distributed, or labeled by Agri Laboratories, Inc., Sparhawk Laboratories, Inc., Jiangxi Tianxin Pharmaceutical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INJECTION

For Animal Use Only

Keep Out of Reach of Children

INDICATIONS

For use as a supplemental source of a complex vitamins in cattle, swine and sheep.

PRECAUTIONS

Allergic-type reactions following the injection of products containing thiamine have veen reported. Administer with caution and keep treated animals under close abservation.

DOSAGE AND ADMINISTRATION

Inject intramuscularly.  May be adminstered subcutaneously or intravenously if recommended by yoru veterinarian. The following are suggested dosages, depending on the condition of the animal and hte desired response.

Adult Cattle - 1 to 2 mL per 100 pounds of body weight

Calves, Swine and Sheep - 5 mL per 100 pounds of body weight.

May be repeated daily, if indicated.

COMPONENTS

Each mL of sterile aqueous solution contains:

ACTIVE INGREDIENTS

Thiamine Hydrochloride (B1) .............................................. 100 mg

Riboflavin (B2) .................................................................... 5 mg

(as Riboflavin 5'-Phosphate Sodium)

Niacinamide .................................................................... 100 mg

Pyridoxine Hydrochloride (B6) ............................................. 10 mg

d-Panthenol ..................................................................... 10 mg

Cyanocobalamin (B12) ..................................................... 100 mg

INACTIVE INGREDIENTS

With Citric Acid and Benzyl Alcohol 1.5% v/v (preservative).

STORAGE AND HANDLING

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

Protect from light.

TAKE TIME OBSERVE LABEL INSTRUCTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTIFIED VITAMIN B COMPLEX 
cyanocobalamin niacinamide depanthenol pyridoxine hydrochloride thiamine hydrochloride riboflavin 5 phosphate sodium injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 57561-606
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	100 ug  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	100 mg  in 1 mL
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)	DEXPANTHENOL	10 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)	FLAVIN MONONUCLEOTIDE	5 mg  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	100 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57561-606-04	100 mL in 1 VIAL
2	NDC: 57561-606-05	250 mL in 1 VIAL
3	NDC: 57561-606-06	500 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/1996

Labeler - Agri Laboratories, Inc. (155594450)

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Tianxin Pharmaceutical Co.		527410270	api manufacture