Vitacore

Manufacturer
Florrax Pharmaceutical Corp.
Effective date
2025-02-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:26:44

Label at a glance#

ProductVitacore
Active ingredientFERROUS BISGLYCINATE, POTASSIUM IODIDE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, MAGNESIUM OXIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-
Label structure12 sections

Storage and handling

STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do not use if seal is broken or missing. MADE IN USA Distributed by: 888-321-2821 Florrax Pharmaceutical Dallas, TX 75161

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Vitacore is a prescription multivitamin/multimineral dietary supplement.

INDICATIONS & USAGE SECTION

Vaticore is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementa­tion, and maintenance of good health is needed.

CONTRAINDICATIONS SECTION

Vaticore is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PRECAUTIONS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Felic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNINGS SECTION

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Florrax Pharmaceuticals at 888-321-2821.

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

HOW SUPPLIED SECTION

Bottles of 30 Tablets (84460-901-30). Tablet is light blue, oblong.

SPL UNCLASSIFIED SECTION

*Florrax Pharmaceuticals does not represent this products code to be National Drug Code
(NDC). Products codes are formatted according to standard industry practice, to meet the
formatting requirement by pedigree reporting and supply-chain control including
pharmacies.
This products is a prescription-folate with or without other dietary ingredients the - due to
increased folate levels increased risk associated with masking B12 deficiency (pernicious
anemia) requires administration under the care of a licensed medical practitioner(64 FR
8760). 1-3 the most appropriate way to ensure pedigree reporting consistent with these
regulatory guidelines and safety monitoring is to dispense this product only by prescription.
This is not an Orange Book product. This product may be administered only under a
physician's supervision and all prescriptions using this product shall be pursuant to state
statues as applicable. The ingredients, indication or claims of this product are not to be
construed to be Drug claims.
1.) Federal register Notice of August 2, 1973 (39 FR 20750)
2.) Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3.) Federal register notice of March 5, 1996 (61 FR 8760)
Storage and Handing

STORAGE AND HANDLING SECTION

STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture.


TAMPER EVIDENT: Do not use if seal is broken or missing.


MADE IN USA
Distributed by:
888-321-2821
Florrax Pharmaceutical
Dallas, TX 75161

OTHER SAFETY INFORMATION

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84460-902-30Vitacore30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84460-902VITACORE (MULTIVITAMIN) TABLET [FLORRAX PHARMACEUTICAL CORP.]11 package rows20250302_2f028036-27a7-63a5-e063-6394a90a1eb7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84460-902-30EA - Each84460-902f703a205-ae2e-4e18-be45-ac99dd88f98912025-03-04

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84460-90284460-902-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2f028036-27a8-63a5-e063-6394a90a1eb72f028036-27a7-63a5-e063-6394a90a1eb72025-02-25Warnings, Adverse reactionsExact identifier
spl id: 2f028036-27a8-63a5-e063-6394a90a1eb7
spl set id: 2f028036-27a7-63a5-e063-6394a90a1eb7

Reported adverse events (FAERS/openFDA)#

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