VITAMIN B COMPLEX
- Manufacturer
- FLON LABORATORIES LLC | Fisiopharma Srl
- Effective date
- 2024-12-11
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:46:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
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.
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.
CONTRAINDICATIONS SECTION
Sensitivity to the ingredients listed
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.
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.
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.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Vitamin B-Complex 100 Injection
NDC 71414-225-01
30 mL Multi-Dose Vial, individually boxed.
Rx Only.
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:
FLON LABORATORIES LLC
Elkhorn, NE 68022 U.S.A
www.flonlabs.com
225PI
REV: 06/17
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71414-225-01 | 2024-12-12 | C162847 | 48780-1 | 9d75b9d0-33f7-f424-e053-dadaa90a57ce | 531dd211-980a-5c36-e054-00144ff88e88 |
| 71414-225-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-33f7-f424-e053-dadaa90a57ce | 531dd211-980a-5c36-e054-00144ff88e88 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71414-225-01 | ML - Milliliter | 71414-225 | 1665adc0-5eae-4057-beba-1dbb490df782 | 1 | 2018-03-08 |
Products#
Every source-derived product name is available through these pages.
- VITAMIN B COMPLEX
- WATER
- HYDROCHLORIC ACID
- THIAMINE HYDROCHLORIDE
- THIAMINE ION
- DEXPANTHENOL
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- BENZYL ALCOHOL
- RIBOFLAVIN 5'-PHOSPHATE SODIUM
- FLAVIN MONONUCLEOTIDE
- SODIUM HYDROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71414-225 | 71414-225-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| THIAMINE HYDROCHLORIDE | M572600E5P | ACTIB |
| DEXPANTHENOL | 1O6C93RI7Z | ACTIB |
| NIACINAMIDE | 25X51I8RD4 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| RIBOFLAVIN 5'-PHOSPHATE SODIUM | 20RD1DZH99 | ACTIM |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4e33bc5a-adac-4d0f-bd08-7a721d0a291a | 531dd211-980a-5c36-e054-00144ff88e88 | 2024-12-11 | Warnings, Adverse reactions | 4e33bc5a-adac-4d0f-bd08-7a721d0a291a 531dd211-980a-5c36-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
