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Name:Vitamin B Complex
Manufacturer:Bioniche Pharma Usa Llc
Category:Prescription Marketed Drugs


VITAMIN B COMPLEX - thiamine hydrochloride, riboflavin 5'-phosphate sodium, dexpanthenol and niacinamide injection 
Bioniche Pharma USA LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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 100mg, Riboflavin 5’ Phosphate Sodium 2mg, Pyridoxine Hydrochloride 2mg, Dexpanthenol 2mg, Niacinamide 100mg, 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 30mL 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.

Rx Only

PROTECT FROM LIGHT: Store in carton until contents are used. Store under refrigeration 2°-8°C (36°-46°F). Do not permit to freeze.

Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045

Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.

Date Prepared: July 2001
Revised: May 2007

0415L103

  

PRINCIPAL DISPLAY PANEL - 30 mL

NDC 67457-146-30

Sterile 30 mL
Multiple Dose Vial

Vitamin
B-Complex
100 Injection

For Intramuscular or
Slow Intravenous Use

Manufactured for:
Bioniche Pharma USA LLC,
Lake Forest, IL 60045

Manufactured by:
Bioniche Teo.,
Inverin, Co. Galway, Ireland.

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.

Protect from Light:
Store in carton until contents
are used.

STORE UNDER REFRIGERATION
2° - 8°C (36° - 46°F).
DO NOT FREEZE.

Directions for Use:
See package insert for full prescribing
information.

Rx only.

Vitamin B Complex Injection Carton

VITAMIN B COMPLEX 
vitamin b complex injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-146
Route of Administration 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
DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 2 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 20 mg  in 1 mL
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-146-30 1 VIAL, MULTI-DOSE ( VIAL) in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (67457-146-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/25/2011

Labeler - Bioniche Pharma USA LLC (790384502)

Revised: 05/2007 Bioniche Pharma USA LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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