Label: VITAMIN B COMPLEX- thiamine hydrochloride, riboflavin 5'-phosphate sodium, dexpanthenol, niacinamide and pyridoxine hydrochloride injection 

  • NDC Code(s): 67457-146-30
  • Packager: Mylan Institutional LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/12

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  • DESCRIPTION

    Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group.

    Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

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  • INDICATIONS AND USAGE

    In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

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  • CONTRAINDICATIONS

    Sensitivity to the ingredients listed.

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  • WARNINGS

    Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.

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  • PRECAUTIONS

    The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously.

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  • ADVERSE REACTIONS

    Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (see WARNINGS). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.

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  • DOSAGE AND ADMINISTRATION

    Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS.)

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see HOW SUPPLIED).

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  • HOW SUPPLIED

    Vitamin B-Complex 100 Injection is available in a 30 mL multiple-dose vial individually boxed.

    Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not redissolve on warming to body temperature and shaking well.

    Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The colour does not affect the safety or efficacy of the product.

    PROTECT FROM LIGHT: Store in carton until contents are used. Store under refrigeration 2° to 8°C (36° to 46°F). Do not permit to freeze.

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    0415L105

    REVISED OCTOBER 2012
    MI:VITBIJ:R2

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  •   

    PRINCIPAL DISPLAY PANEL - 30 mL

    NDC 67457-146-30     30 mL

    Vitamin
    B-Complex
    100 Injection

    For Intramuscular or
    Slow Intravenous Use

    Rx only     Multi-Dose Vial

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    MI:146:1C:R2

    Mylan.com

    Sterile

    Each mL contains: Thiamine HCl
    100 mg, Riboflavin 5' Phosphate
    Sodium 2 mg, Pyridoxine HCl
    2 mg, Dexpanthenol 2 mg,
    Niacinamide 100 mg, with Benzyl
    Alcohol 2% as preservative, in
    Water for Injection. Sodium
    Hydroxide and/or Hydrochloric
    Acid may have been used to
    adjust pH.

    Warning: Anaphylactogenesis to
    parenteral thiamine has been
    reported.

    Use with caution.

    Usual Dosage: See accompanying
    prescribing information.

    STORE UNDER
    REFRIGERATION 2° TO 8°C
    (36° TO 46°F).

    DO NOT FREEZE.

    Protect from light.

    Store in carton until contents are
    used.

    Vitamin B-Complex 100 Injection Carton Labels
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  • INGREDIENTS AND APPEARANCE
    VITAMIN B COMPLEX 
    thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-146
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 100 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 2 mg  in 1 mL
    DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 2 mg  in 1 mL
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 100 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL 20 mg  in 1 mL
    WATER  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67457-146-30 1 in 1 CARTON
    1 30 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/10/2013
    Labeler - Mylan Institutional LLC (790384502)
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