SPL UNCLASSIFIED SECTION
Thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol, niacinamide and pyridoxine injection
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. Use with caution. 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. (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
Rx Only
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.
Manufactured for:
Raw Materials International Overseas LLC
Miami Beach, FL 33140
United States
Rev. 07/15
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69877-026-01 | 2024-12-13 | C162847 | 48780-1 | 9d75b9d0-d7da-f424-e053-dadaa90a57ce | Vitamin B complex |
| 69877-026-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d7da-f424-e053-dadaa90a57ce | Vitamin B complex |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXPANTHENOL | ACTIVE INGREDIENT | 1O6C93RI7Z | 2 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 2 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 2 | |
| RIBOFLAVIN 5'-PHOSPHATE SODIUM | ACTIVE INGREDIENT | 20RD1DZH99 | 2 | |
| THIAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | M572600E5P | 2 | |
| DEXPANTHENOL | ACTIVE MOIETY | 1O6C93RI7Z | 2 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 2 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 2 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 2 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69877-026 | 69877-026-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| RIBOFLAVIN 5'-PHOSPHATE SODIUM | 20RD1DZH99 | ACTIM |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| DEXPANTHENOL | 1O6C93RI7Z | ACTIB |
| NIACINAMIDE | 25X51I8RD4 | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| THIAMINE HYDROCHLORIDE | M572600E5P | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SPRAY / RESPIRATORY (INHALATION) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EPIDURAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRASYNOVIAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRASPINAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVASCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATUMOR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SOFT TISSUE | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER, FOR SUSPENSION / ORAL | 125 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBCUTANEOUS | 1 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DROPS / OPHTHALMIC | NA | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | LIQUID / NASAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / RESPIRATORY (INHALATION) | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRALESIONAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / OPHTHALMIC | 0.02 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CAPSULE, LIQUID FILLED / ORAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRATHECAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CONCENTRATE / ORAL | 2.17 mg/1ml | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / INTRATYMPANIC | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / PARENTERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAVENOUS | 1620 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRACAUDAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / TOPICAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRALESIONAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBCONJUNCTIVAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / VAGINAL | 100 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SYRUP / ORAL | 2.03 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-AMNIOTIC | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IONTOPHORESIS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAPERITONEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 654aa6f5-e71b-4e8a-a149-4d5a3e9f4f2e | 1a3a8ac6-39a6-6525-e054-00144ff8d46c | 2024-12-13 | Warnings, Adverse reactions | 654aa6f5-e71b-4e8a-a149-4d5a3e9f4f2e 1a3a8ac6-39a6-6525-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.