Generic Name: thiamine hydrochloride, riboflavin 5 phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide Support Group Q & A 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. Thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol, niacinamide and pyridoxine injection 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.
Sensitivity to the ingredients listed. Anaphylactogenesis may occur with parenteral thiamine. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug. 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. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (See HOW SUPPLIED).
NDC 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 2° to 8°C (36° to 46°F). Do not permit to freeze. Raw Materials International Overseas LLC Miami Beach, FL 33140 HUMAN PRESCRIPTION DRUG LABEL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) 2 mg in 1 mL 100 mg in 1 mL THIAMINE HYDROCHLORIDE (THIAMINE ION) 20 mg in 1 mL 1 VIAL, MULTI-DOSE in 1 BOX 30 mL in 1 VIAL, MULTI-DOSE Application Number or Monograph Citation
Raw Materials International Overseas LLC (079829477)Vitamin B12 is an essential water-soluble vitamin. It is found in an assortment of foods including dairy products, meat and fish. Vitamin B12 is important for growth, the reproduction of cells, blood formation, as well as the synthesizing of protein and tissue. Vitamin B12 is conjoined to the protein in food and is often mixed with other B vitamins to create a complex formula. Since the human body can stockpile many years worth of vitamin B12 deficiency of this nutrient is extremely rare. However, the elderly and vegetarians can be vulnerable to a vitamin B12 deficit as are those who suffer from a disease known as pernicious anemia. This condition makes the body unable to absorb vitamin B12 from the intestinal tract. In such cases it may be necessary to intravenously administer vitamin B 12 into the bloodstream to sidestep the absorption process. Doctors sometimes prescribe vitamin B12 injections to pernicious anemia patients as well as people with chronic fatigue syndrome, stress and other conditions.
Vitamin B12 injections are often delivered in a man-made form of the vitamin known as cyanocobalamin. Cyanocobalamin is soaked up quickly in the muscles at the injection site. In addition to B12, the ingredients of cyanocobalamin injections are sodium chloride (common table used as a preservative), sodium hydroxide (a strongly alkaline caustic used in various sodium compounds), hydrochloric acid (corrosive acid used mainly for dissolving unwanted substance) and benzyl alcohol (as a preservative). All of these added substances are listed as inactive ingredients in cyancobalamin. Cyanocobalamin is blended in a clear red, sterile and non-pyrogenic (does not produce fever) solution. The hygroscopic (readily absorbs moisture) solution is water soluble. Cyancobalamin injections are typically given in 1,000 mcg doses. The plasma (watery fluid of the blood) level of the compound reaches its peak within one hour following delivery. At least half of the vitamin B12 received in the shot is excreted in the urine within 48 hours.
B12 Injections Side Effects How to Inject B12 Via the Buttocks The Best Method to Increase Vitamin B12 Levels Vitamin B12 Test Range The Side Effects of Vitamin B12 Lipotropic Injections B12 Deficiency Symptoms and Hair Loss Vitamin B12 Drug Side Effects How is a B12 Injection Given? Adverse Reactions to Vitamin B12 Shots B12 Shots Vs. B12 Liquid Chronic Gastritis & B-12 Deficiency B12 & B Complex Injections How to Take Vitamin B-12 at Night The Best Way to Give a B12 Shot Symptoms of Vitamin B-12 Deficiency Vitamin C Deficiency & Anemia Problems With the Vitamin B12 Shot Vitamin B12 Benefits & Side Effects Vitamin B-12 Deficiency & Paresthesia Generic Name: vitamin-b-complex - thiamine hydrochloride, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide Dosage Form: injection, solution 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. 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. PRECAUTIONS: The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. 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. 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. 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. Refrigeration of the product may cause darkening of the solution due to the riboflavin content. PROTECT FROM LIGHT: Store in carton until contents are used. Store under refrigeration 2 deg - 8 deg C (36 deg - 46 deg F).