FDA.reportPublic FDA data

Fortified Vitamin B Complex

Manufacturer
IBA, Inc.
Effective date
2019-07-23
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:40:28

Label at a glance#

ProductFortified Vitamin B Complex
Active ingredientCYANOCOBALAMIN, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, RIBOFLAVIN 5'-PHOSPHATE SODIUM
Label structure6 sections

Dosage and administration

Inject intramuscularly. May be administered subcutaneously or intravenously if recommended by your veterinarian. The following are suggested dosages, depending on the condition of the animal and the desired response. Adult Cattle- 1 to 2 mL per 100 pounds of body weight. Calves, Swine and Sheep- 5 mL per 100 pounds of body weight. May be repeated as indicated.

Storage and handling

Store at controlled room temperature between 15° and 30°C (59°-86°F) Protect from light. TAKE TIME OBSERVE LABEL DIRECTIONS

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

For use as a supplemental source of B complex vitamins in cattle, swine and sheep.

PRECAUTIONS

PRECAUTIONS SECTION

Allergic-type reactions following the injection of products containing thiamine have been reported. Administer with caution and keep treated animals under close observation.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Inject intramuscularly. May be administered subcutaneously or intravenously if recommended by your veterinarian. The following are suggested dosages, depending on the condition of the animal and the desired response.

Adult Cattle- 1 to 2 mL per 100 pounds of body weight.

Calves, Swine and Sheep- 5 mL per 100 pounds of body weight.

May be repeated as indicated.

COMPOSITION

COMPONENTS

Each mL of sterile aqueous solution contains:

Thiamine Hydrochloride (B1) .................................. 100 mg

Niacinamide ......................................................... 100 mg

Pyridoxine Hydrochloride (B6) .................................. 10 mg

d-Panthenol ........................................................... 10 mg

Riboflavin (B2) ........................................................ 5 mg

   (as Riboflavin 5'-Phosphate Sodium)

Cyanocobalamin (B12) ......................................... 100 mcg

With Citric Acid and Benzyl Alcohol 1.5% v/v (preservative).

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 15° and 30°C (59°-86°F)

Protect from light.

TAKE TIME OBSERVE LABEL DIRECTIONS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBA HiPo BIBA HiPo B

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1314626dexpanthenol 10 MG/ML / niacinamide 100 MG/ML / pyridoxine hydrochloride 10 MG/ML / riboflavin 5 MG/ML / thiamine hydrochloride 100 MG/ML / vitamin B12 0.1 MG/ML Injectable SolutionSCD2
1314626dexpanthenol 10 MG/ML / niacinamide 100 MG/ML / vit-B6 hydrochloride 10 MG/ML / riboflavin 5 MG/ML / vit-B1 hydrochloride 100 MG/ML / vitamin B12 0.1 MG/ML Injectable SolutionSY2
1314626dexpanthenol 10 MG/ML / niacinamide 100 MG/ML / vit-B6 hydrochloride 10 MG/ML / riboflavin 5 MG/ML / vitamin B1 hydrochloride 100 MG/ML / vitamin B12 0.1 MG/ML Injectable SolutionSY2
1314626dexpanthenol 10 MG/ML / niacinamide 100 MG/ML / vitamin B6 hydrochloride 10 MG/ML / riboflavin 5 MG/ML / vit-B1 hydrochloride 100 MG/ML / vitamin B12 0.1 MG/ML Injectable SolutionSY2
1314626dexpanthenol 10 MG/ML / niacinamide 100 MG/ML / vitamin B6 hydrochloride 10 MG/ML / riboflavin 5 MG/ML / vitamin B1 hydrochloride 100 MG/ML / vitamin B12 0.1 MG/ML Injectable SolutionSY2
1314626veterinary high potency vitamin B complex Injectable SolutionSY2
1314626vitamin B1 100 MG/ML / vitamin B2 5 MG/ML / vitamin B3 100 MG/ML / vitamin B5 10 MG/ML / vitamin B6 10 MG/ML / vitamin B12 100 MCG/ML Injectable SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
RIBOFLAVIN 5'-PHOSPHATE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29983-2713-1Fortified Vitamin B Complex250 mL in 1 VIALINJECTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29983-2713FORTIFIED VITAMIN B COMPLEX (THIAMINE HYDROCHLORIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE DEXPANTHANOL RIBOFLAVIN 5 PHOSPHATE SODIUM CYANOCOBALAMIN) INJECTION [IBA, INC.]21 package rows20190724_baa08472-70b0-4e61-bb21-e1ff90c84360.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29983-271329983-2713-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYANOCOBALAMINP6YC3EG204ACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
NIACINAMIDE25X51I8RD4ACTIB
DEXPANTHENOL1O6C93RI7ZACTIB
RIBOFLAVIN 5'-PHOSPHATE SODIUM20RD1DZH99ACTIM

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst54f088b1-7cf8-3837-e063-6294a90a88e72026-09-02Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINLifestar Pharma LLCb1e35c97-2157-454e-967f-53a4300827de2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINNorthStar RxLLCce0183b3-4410-466a-b57d-cd360d461b7c2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
Non-proprietary nameCYANOCOBALAMINXseer Pharmaceuticals3bb870d8-128d-75ea-e063-6394a90a707b2026-05-13Name fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINPlano Pharmaceuticals Inc.4cbc05f6-4b31-4a5f-e063-6394a90a676c2026-03-25Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSportpharm LLC647842f4-b211-4f52-8b73-975fae7670232026-02-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINA-S Medication Solutionsa61181f5-7e2d-45f9-929a-cb8bc70c992e2026-01-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINSOLA Pharmaceuticalse559c6c8-2973-77fb-e053-2995a90af43d2025-12-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINBluePoint Laboratories5c603ad0-9023-44cc-955c-3988d5dcf0d32025-12-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHenry Schein, Inc.ff32f34b-89b3-4617-ad42-2e8bcb88627e2025-10-16Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINHenry Schein, Inc.92f08572-cfd9-4a99-bb49-937ab94eeb622025-09-10Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSomerset Therapeutics, LLC41ac0dc1-0a71-4c69-8e25-ba838f5f16a32025-09-04Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINSomerset Therapeutics, LLC617e44f8-df80-4764-85b9-be0fb6da8db32025-08-29Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.064c6841-3ed2-417f-a77c-a730785b60362025-06-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst9d4ac337-5f4d-ef47-e053-2a95a90a6dbf2025-01-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.9c37fd25-2143-410c-8d89-d39aa5c7b4532024-11-22Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.c6436212-9246-4e29-8540-9af992b667eb2024-06-03Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.