Vitamin B Complex by is a Prescription medication manufactured, distributed, or labeled by Mylan Institutional LLC. Drug facts, warnings, and ingredients follow.
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.
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.
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.
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).
Vitamin B-Complex 100 Injection is available in a 30 mL 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.
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:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
Manufactured by:
Mylan Institutional
Galway, Ireland
0415L106
Revised: 10/2017
MI:VITBIJ:R3
NDC: 67457-146-30 30 mL
Vitamin
B-Complex
100 Injection
For Intramuscular or
Slow Intravenous Use
Rx only Multi-Dose Vial
Sterile
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.
Usual Dosage: See accompanying
prescribing information.
STORE UNDER
REFRIGERATION 2° TO 8°C
(36° TO 46°F).
DO NOT FREEZE.
Protect from light.
Store in carton until contents are
used.
Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
Manufactured by:
Mylan Institutional
Galway, Ireland
MI:146:1C:R3
Mylan.com
VITAMIN B COMPLEX
thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide injection |
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Labeler - Mylan Institutional LLC (790384502) |