{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-18",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Vitamin B Complex thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN 5'-PHOSPHATE SODIUM FLAVIN MONONUCLEOTIDE DEXPANTHENOL DEXPANTHENOL NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE BENZYL ALCOHOL WATER HYDROCHLORIC ACID SODIUM HYDROXIDE"
      ],
      "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 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": [
        "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": [
        "CONTRAINDICATIONS Sensitivity to the ingredients listed."
      ],
      "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."
      ],
      "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."
      ],
      "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 may occur (see WARNINGS ). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted."
      ],
      "dosage_and_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 permit (see HOW SUPPLIED )."
      ],
      "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 Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0415L107 Revised: 9/2021 MI:VITBIJ:R4"
      ],
      "package_label_principal_display_panel": [
        "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 Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland MI:146:1C:R4 Mylan.com Vitamin B-Complex 100 Injection Carton Label"
      ],
      "set_id": "282ccec8-9bcd-4571-9b91-bbb96ef2620d",
      "id": "a7704aa3-bd3d-479e-8469-767d59636c7e",
      "effective_time": "20210915",
      "version": "8",
      "openfda": {
        "brand_name": [
          "Vitamin B Complex"
        ],
        "generic_name": [
          "THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE"
        ],
        "manufacturer_name": [
          "Mylan Institutional LLC"
        ],
        "product_ndc": [
          "67457-146"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXPANTHENOL",
          "NIACINAMIDE",
          "PYRIDOXINE HYDROCHLORIDE",
          "RIBOFLAVIN 5'-PHOSPHATE SODIUM",
          "THIAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "801177"
        ],
        "spl_id": [
          "a7704aa3-bd3d-479e-8469-767d59636c7e"
        ],
        "spl_set_id": [
          "282ccec8-9bcd-4571-9b91-bbb96ef2620d"
        ],
        "package_ndc": [
          "67457-146-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1O6C93RI7Z",
          "25X51I8RD4",
          "68Y4CF58BV",
          "20RD1DZH99",
          "M572600E5P"
        ]
      }
    }
  ]
}