Folartex Tablet
FDA Label NDC 85477-511

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Folartex (NDC 85477-511). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, contraindications, precautions, warnings, adverse reactions, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

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

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

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

Precautions

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

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

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

One tablet daily or as directed by a physician.

How Supplied

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

Storage

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

85477-511-30
Folarex
MULTIVITAMIN
30 TABLETS

85477-511-30folarexmultivitamin30 Tablets (Folarex 01)

85477-511-30folarexmultivitamin30 Tablets (Folarex 01)

Oncora Pharma, LLC

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