VITAMIN B COMPLEX (THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE) INJECTION [MYLAN INSTITUTIONAL LLC]

VITAMIN B COMPLEX (THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE) INJECTION [MYLAN INSTITUTIONAL LLC]
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NDC 67457-146-30
Set ID 282ccec8-9bcd-4571-9b91-bbb96ef2620d
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Mylan Institutional LLC
Generic Name
Product Class
Product Number
Application Number
  • 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.

  • 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.

  • CONTRAINDICATIONS

    Sensitivity to the ingredients listed.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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

    0415L106

    Revised: 10/2017
    MI:VITBIJ:R3

  • 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

    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.

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

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    MI:146:1C:R3

    Mylan.com

    Vitamin B-Complex 100 Injection Carton Label
  • INGREDIENTS AND APPEARANCE
    VITAMIN B COMPLEX 
    thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67457-146
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE100 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE2 mg  in 1 mL
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL2 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE100 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 20 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67457-146-301 in 1 CARTON05/10/2013
    130 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other05/10/2013
    Labeler - Mylan Institutional LLC (790384502)