Label: B-PLEX 100- thiamine hydrochloride, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 07/13

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  • DESCRIPTION

    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 100mg, Riboflavin 5' Phosphate Sodium 2mg, Pyridoxine Hydrochloride 2mg, Dexpanthenol 2mg, 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 & USAGE

    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

    CONTRAINDICATIONS: Sensitivity to the ingredients listed.

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  • WARNINGS

    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

    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

    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 my 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 & ADMINISTRATION

    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 permint (See How Supplied).

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  • HOW SUPPLIED

    HOW SUPPLIED:  Vitamin B-Complex 100 Injection is available in a 30mL 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.

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • STORAGE AND HANDLING

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

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Bioniche Pharma USA LLC,
    Lake Forest, IL 60045

    Manufactured by:
    Bioniche Teo.,
    Inverin, Co. Galway, Ireland

    Date Prepared:  July 2001

    Revised:  May 2007

    0415L103

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  • INGREDIENTS AND APPEARANCE
    B-PLEX 100 
    thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, dexpanthenol, niacinamide injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30727-300
    Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Thiamine Hydrochloride (Thiamine Ion) Thiamine Hydrochloride 100 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 2 mg  in 1 mL
    Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2 mg  in 1 mL
    Dexpanthenol (Dexpanthenol) Dexpanthenol 2 mg  in 1 mL
    Niacinamide (Niacinamide) Niacinamide 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Hydroxide  
    Benzyl Alcohol  
    Water  
    Hydrochloric Acid  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30727-300-80 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 01/01/2012
    Labeler - Merit Pharmaceutical (093370369)
    Registrant - Merit Pharmaceutical (093370369)
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