Vitamin B Complex

Dosage Form: injection, solution

Vitamin B Complex 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 the 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 precipitate occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when giving 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 is Vitamin B Complex Supplied

Vitamin B-Complex 100 Injection is available in a 30 ml multiple dose vial individually boxed (NDC 67157-108-30) or in a 5 vial shelf pack (NDC 67157-108-31).

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 re-dissolve on warming to body temperature and shaking well.

Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The color does not affect the safety or efficacy of the product.

PROTECT FROM LIGHT:

Store in carton until contents are used. Store under refrigeration 2oC – 8oC (36oF – 46oF). Do not permit to freeze.

Rx ONLY

Manufactured By:

McGuff Pharmaceuticals, Inc. Santa Ana, CA 92704 U.S.A. 

MD381-0024 rev: NEW 8/2009

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

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67157-108 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 100 mg  in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 5'-PHOSPHATE SODIUM 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 BENZYL ALCOHOL 2 mL  in 100 mL WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67157-108-30 1 VIAL In 1 PACKAGE contains a VIAL, MULTI-DOSE 1 30 mL In 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (67157-108-30) 2 67157-108-31 5 VIAL In 1 PACKAGE contains a VIAL, MULTI-DOSE 2 30 mL In 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (67157-108-31)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/25/2010

Labeler - McGuff Pharmaceuticals Inc. (134632103)

Establishment
Name	Address	ID/FEI	Operations
McGuff Pharmaceuticals Inc.		134632103	manufacture

Revised: 01/2010McGuff Pharmaceuticals Inc.

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