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B-Plex 100 Injection

Generic Name: vitamin-b-complex - thiamine hydrochloride, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide
Dosage Form: injection, solution

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.

VITAMIN B-COMPLEX 100 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 100mg, Riboflavin 5' Phosphate Sodium 2mg, Pyridoxine Hydrochloride 2mg, Dexpanthenol 2mg, 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:  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 my 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 permint (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 deg - 8 deg C (36 deg - 46 deg 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

B-PLEX 100 
thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, dexpanthenol, niacinamide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:30727-300
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Thiamine Hydrochloride (Thiamine Ion) Thiamine Hydrochloride 100 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 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
Sodium Hydroxide  
Benzyl Alcohol  
Water  
Hydrochloric Acid  
Packaging
# Item Code Package Description
1 NDC:30727-300-80 1 VIAL, MULTI-DOSE (VIAL) 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 01/01/2012
Labeler - Merit Pharmaceutical (093370369)
Registrant - Merit Pharmaceutical (093370369)
Revised: 07/2013
 
Merit Pharmaceutical



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