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

Vitamin B Complex by

Drug Labeling and Warnings

Vitamin B Complex by is a Prescription medication manufactured, distributed, or labeled by Raw Materials International Overseas LLC, Fisiopharma Srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol, niacinamide and pyridoxine injection

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 & 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 & 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

Rx Only

NDC: 69877-026-01 30 mL Multi-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:

Raw Materials International Overseas LLC
Miami Beach, FL 33140

United States

Rev. 07/15

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITAMIN B COMPLEX 
thiamine hydrochloride, riboflavin 5 phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69877-026
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	2 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	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
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	20 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69877-026-01	1 in 1 BOX
1		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/06/2015

Labeler - Raw Materials International Overseas LLC (079829477)