Folartex

Manufacturer
Oncora Pharma, LLC
Effective date
2026-02-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:07:01

Label at a glance#

ProductFolartex
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, MAGNESIUM OXIDE, FERROUS BISGLYCINATE, POTASSIUM IODIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

One tablet daily or as directed by a physician.

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 contro  l ed 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 Oncora Pharma Da  l as, TX 75161

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Folarex

DESCRIPTION

DESCRIPTION SECTION

Folarex is a prescription multivitamin/multimineral dietary supplement.

SUPPLEMENT FACTS
Servingsize
Amount per serving:
1tablet
% Daily   Value
Vitamin A (as Beta-Carotene)300 mcg RAE33%
Vitamin C (as Ascorbic Acid)60mg67%
Vitamin D (as Cholecalciferol)10mcg50%
Vitamin E (as di-Alpha Tocopherol Acetate)4.5 mg (10 IU)33%
Vitamin 86 (as Pyrldoxine HCI)26mg1529%
Biotin0.280mg933%
Folate1.67 mg DFE418%
(from Folic Acid)0.67 mg DFE
(from 5 Methyl Tetrahydrotolate Calcium Salt)1 mg DFE
Vitamin 812 (as Cyanocobalamin)0.013 mg542%
Calcium (as Calcium Carbonate)80 mg6%
Magnesium (as Magnesium Oxide)25mg6%
Ferrochel""20mg111mg
Iodine (as Potassium Iodide)0.150mg100%

Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

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

WARNINGS

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   REACH   OF   CHILDREN. In the case of accidental overdose, ca l  a doctor or poison control center immediately.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.

STORAGE

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 contro led 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
Oncora Pharma Da las, TX 75161

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85477-511-30
Folarex
MULTIVITAMIN
30 TABLETS

85477-511-30 Folarex MULTIVITAMIN 30 TABLETS85477-511-30 Folarex MULTIVITAMIN 30 TABLETS

Oncora Pharma, LLC

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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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-511-30Folartex30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-511-30EA - Each85477-5116cb2d226-86aa-47ef-b7b8-84867b5eff7112026-04-20

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-51185477-511-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
FolartexMULTIVITAMINOncora Pharma, LLC0a4cb0ab-565f-45e8-a989-740bccef21cd2026-02-25Warnings, Adverse reactionsExact identifier
ndc (package): 85477-511-30
ndc (product): 85477-511
ndc11 (package): 85477051130
spl id: a9886a49-ba1d-44f5-96e5-26c927d6db9c
spl set id: 0a4cb0ab-565f-45e8-a989-740bccef21cd

Reported adverse events (FAERS/openFDA)#

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