ADVERSE REACTIONS SECTION.

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.

CONTRAINDICATIONS SECTION.

Sensitivity to the ingredients listed.

DESCRIPTION SECTION.

Vitamin B-Complex 100 Injection is sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin complex group.Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin Phosphate Sodium mg, Pyridoxine Hydrochloride mg, Dexpanthenol 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.

DOSAGE & ADMINISTRATION SECTION.

Usually 0.25 to 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 SECTION.

Vitamin B-Complex 100 InjectionRx OnlyNDC 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 to 8C (36 to 46F). Do not permit to freeze.Manufactured for:Raw Materials International Overseas LLC Miami Beach, FL 33140 United StatesRev. 07/15.

INDICATIONS & USAGE SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

single box.

PRECAUTIONS SECTION.

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.

SPL UNCLASSIFIED SECTION.

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

WARNINGS SECTION.

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.