NDC | 57561-606-04, 57561-606-05, 57561-606-06 |
Set ID | fe35274e-755f-48de-89ae-72d9c3b8ab2f |
Category | OTC ANIMAL DRUG LABEL |
Packager | Agri Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
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- INDICATIONS & USAGE
- PRECAUTIONS
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORTIFIED VITAMIN B COMPLEX
cyanocobalamin niacinamide depanthenol pyridoxine hydrochloride thiamine hydrochloride riboflavin 5 phosphate sodium injectionProduct 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