Label: VITAMIN B COMPLEX FORTIFIED- thiamine hydrochloride niacinamide pyridoxine hydrochloride dexpanthanol riboflavin 5 phosphate sodium cyanocobalamin injection

  • NDC Code(s): 57319-514-05, 57319-514-06
  • Packager: Clipper Distributing Company LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 23, 2019

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  • COMPONENTS

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    EACH mL CONTAINS

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

    Riboflavin (B12) ..................................... 5 mg
       (as Riboflavin 5'-Phosphate Sodium)

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

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

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

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

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

  • INDICATIONS

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

  • DOSAGE AND ADMINISTRATION

    Inject intramuscularly. May be administered subcutaneously or intravenously if recommended by your veterinarian. The following are suggested by your veterinarian. The following are suggested dosages, depending on the condition of the animal and the 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.

  • PRECAUTIONS

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

  • 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

    PX-Vit B Complex Fortified

  • INGREDIENTS AND APPEARANCE
    VITAMIN B COMPLEX FORTIFIED 
    thiamine hydrochloride niacinamide pyridoxine hydrochloride dexpanthanol riboflavin 5 phosphate sodium cyanocobalamin injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57319-514
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.1 mg  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE100 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE100 mg  in 1 mL
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL10 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-514-05100 mL in 1 VIAL
    2NDC:57319-514-06250 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/15/2006
    Labeler - Clipper Distributing Company LLC (150711039)