NDC | 57561-611-04, 57561-611-05 |
Set ID | d69d0818-ddd4-411f-a578-8cce22c70ebb |
Category | OTC ANIMAL DRUG LABEL |
Packager | Agri Laboratories, Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INDICATIONS & USAGE
For Animal Use Only
Keep Out of Reach of Children
INDICATIONS
For us as a supplemental source of a complex vitamins in cattle, swine and sheep.
Close - PRECAUTIONS
Hypersensitivity reactions to the parenteral administration of products containing thiamine have been reported. Administer with caution and keep treated animals under close observation.
Close - DOSAGE AND ADMINISTRATION
Subcutaneous or Intramuscular injection is recommended. May be administered intravenously at the discretion of a veterinarian. The following are suggested dosages, depending on the condition of the animal and the desired response.
Adult Cattle- 1 to 2 mL per 500 pounds of body weight.
Calves, Swine and Sheep- 1 to 2 mL.
May be repeated once or twice weekly.
Close - COMPONENTS
Each mL of sterile aqueous solution contains:
Thiamine Hydrochloride (B1) .................................... 1.25 mg
Niacinamide ........................................................... 12.5 mg
Pyridoxine Hydrochloride (B6) .................................... 5.0 mg
d-Panthenol ............................................................. 5.0 mg
Riboflavin (B2) ......................................................... 2.0 mg
(as Riboflavin 5' phosphate sodium)
Cyanocobalamin (B12) ........................................... 1000 mcg
with Benzyl Alcohol 1.5% v/v as a preservative, Ammonium Sulfate 0.1%
Close - STORAGE AND HANDLING
Store at controlled room temperature between 15° and 30°C (59° - 86°F)
Protect from light.
TAKE TIME OBSERVE LABEL DIRECTIONS
Close - INGREDIENTS AND APPEARANCE
B-COMPLEX-PLUS
cyanocobalamin niacinamide pyridoxine hydrochloride dexpanthenol riboflavin 5 phosphate sodium injectionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57561-611 Route of Administration SUBCUTANEOUS, INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.25 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 12.5 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 5 mg in 1 mL DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL 5 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE 2 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57561-611-04 100 mL in 1 VIAL 2 NDC:57561-611-05 250 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/18/2007 Labeler - Agri Laboratories, Ltd. (155594450)