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VITAMIN B COMPLEX

Approved
Approval ID

531dd211-980a-5c36-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 29, 2017

Manufacturers
FDA

FLON LABORATORIES LLC

DUNS: 080592497

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VITAMIN B COMPLEX

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71414-225
Product Classification
G
Generic Name
VITAMIN B COMPLEX
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateSeptember 29, 2017
FDA Product Classification

INGREDIENTS (9)

DEXPANTHENOLActive
Quantity: 2 mg in 1 mL
Code: 1O6C93RI7Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
THIAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: M572600E5P
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NIACINAMIDEActive
Quantity: 100 mg in 1 mL
Code: 25X51I8RD4
Classification: ACTIB
RIBOFLAVIN 5'-PHOSPHATE SODIUMActive
Quantity: 2 mg in 1 mL
Code: 20RD1DZH99
Classification: ACTIM
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 68Y4CF58BV
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 20 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/1/2017

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

LOINC: 34070-3Updated: 4/1/2017

Sensitivity to the ingredients listed

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 4/1/2017

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.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 4/1/2017

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2017

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

LOINC: 42232-9Updated: 4/1/2017

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2017

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

LOINC: 34069-5Updated: 4/1/2017

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

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VITAMIN B COMPLEX - FDA Drug Approval Details