Label: VITAMIN B COMPLEX- thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection
- NDC Code(s): 67457-146-30
- Packager: Mylan Institutional LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated March 31, 2012
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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.Close
- 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.Close
Sensitivity to the ingredients listed.Close
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.Close
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.Close
- 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.Close
- 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).Close
- 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.
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
REVISED OCTOBER 2012Close
PRINCIPAL DISPLAY PANEL - 30 mL
NDC 67457-146-30 30 mL
For Intramuscular or
Slow Intravenous Use
Rx only Multi-Dose Vial
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
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
Warning: Anaphylactogenesis to
parenteral thiamine has been
Use with caution.
Usual Dosage: See accompanying
REFRIGERATION 2° TO 8°C
(36° TO 46°F).
DO NOT FREEZE.
Protect from light.
Store in carton until contents areClose
- INGREDIENTS AND APPEARANCE
VITAMIN B COMPLEX
thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-146 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 100 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 2 mg in 1 mL DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL 2 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 100 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 20 mg in 1 mL WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) 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)