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Prescription products · Product label record

Folaten drug information

MULTIVITAMIN
Oncora Pharma, LLC · ORAL

Product NDC: 85477-901

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMULTIVITAMIN
Labeler / manufacturerOncora Pharma, LLC
RouteORAL
Drug classVitamin C / Vitamin D / Vitamin B12
Product NDC85477-901
Label effective date2026-02-12

Official product label reference

Folaten — Oncora Pharma, LLC

This page contains 9 source sections for MULTIVITAMIN, oral route. Label set 93086235-2c33-424d-b0c3-213031988581, version 3.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

INDICATIONS AND USAGE Folaten 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.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician.
Contraindications
CONTRAINDICATIONS Folaten is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
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, call a doctor or poison control center immediately.
Adverse reactions
ADVERSE REACTIONS 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 Oncora Pharma at 888-321-2821.
Product description
DESCRIPTION Folaten is a prescription multivitamin/multimineral dietary supplement. SUPPLEMENT FACTS Serving size Amount per serving: 1 tablet % Daily Value Vitamin A (as Beta-Carotene) 300 mcg RAE 33% Vitamin C (as Ascorbic Acid) 60mg 67% Vitamin D (as Cholecalciferol) 10mcg 50% Vitamin E (as di-Alpha Tocopherol Acetate) 4.5 mg (10 IU) 33% Vitamin 86 (as Pyrldoxine HCI) 26mg 1529% Biotin 0.280mg 933% Folate 1.67 mg □FE 418% (from Folic Acid) 0.67 mg □FE (from 5 Methyl Tetrahydrotolate Calcium Salt) 1 mg DFE Vitamin 812 (as Cyanocobalamin) 0.013 mg 542% Calcium (as Calcium Carbonate) 80 mg 6% Magnesium (as Magnesium Oxide) 25mg 6% Ferrochel"" 20mg 111mg Iodine (as Potassium Iodide) 0.150mg 100% Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1 Table text from source: | SUPPLEMENT FACTS | ServingsizeAmount per serving: | | 1tablet% Daily Value | Vitamin A (as Beta-Carotene) | 300 mcg RAE | 33% | Vitamin C (as Ascorbic Acid) | 60mg | 67% | Vitamin D (as Cholecalciferol) | 10mcg | 50% | Vitamin E (as di-Alpha Tocopherol Acetate) | 4.5 mg (10 IU) | 33% | Vitamin 86 (as Pyrldoxine HCI) | 26mg | 1529% | Biotin | 0.280mg | 933% | Folate | 1.67 mg □FE | 418% | (from Folic Acid) | 0.67 mg □FE | | (from 5 Methyl Tetrahydrotolate Calcium Salt) | 1 mg DFE | | Vitamin 812 (as Cyanocobalamin) | 0.013 mg | 542% | Calcium (as Calcium Carbonate) | 80 mg | 6% | Magnesium (as Magnesium Oxide) | 25mg | 6% | Ferrochel"" | 20mg | 111mg | Iodine (as Potassium Iodide) | 0.150mg | 100% | Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1
Precautions
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.
Supply and packaging
HOW SUPPLIED Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.
Storage and handling
STORAGE 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 Oncora Pharma Dallas, TX 75161

Official sources and product identifiers

Substances listed: BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, MAGNESIUM OXIDE, FERROUS BISGLYCINATE, POTASSIUM IODIDE

Package NDC codes

85477-901-30

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.