Folaten

Drug Facts

Composition & Product

Active Ingredients

Beta Carotene (300 ug) Ascorbic Acid (60 mg) Cholecalciferol (10 ug) .alpha.-tocopherol, Dl- (4.5 mg) Pyridoxine (26 mg) Biotin (0.28 mg) Folic Acid (1.67 mg) Cyanocobalamin (0.013 mg) Calcium Cation (80 mg) Magnesium Cation (25 mg) Ferrous Cation (20 mg) Iodide Ion (0.15 mg)

Inactive Ingredients

Cellulose, Microcrystalline Maltodextrin Croscarmellose Sodium Silicon Dioxide Stearic Acid Magnesium Stearate Hydroxypropyl Methylcellulose Polyethylene Glycol 1000 Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Shape: oval Color: brown Size: 19 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2026-01-01

Medication Information

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

One tablet daily or as directed by a physician.

Contraindications

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

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.

How Supplied

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

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

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

Warnings

WARNINGAccidental 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.

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.

Principal Display Panel

Structured Label Content

Storage (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

Warnings (WARNINGS)

WARNINGAccidental 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.

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

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.

How Supplied (HOW SUPPLIED)

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

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.

Contraindications (CONTRAINDICATIONS)

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

Indications and Usage (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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (DOSAGE AND ADMINISTRATION)

One tablet daily or as directed by a physician.

Advanced Ingredient Data

[{"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL METHYLCELLULOSE", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 1000", "unii": "U076Q6Q621", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BETA CAROTENE", "unii": "01YAE03M7J", "classCode": "ACTIB", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHOLECALCIFEROL", "unii": "1C6V77QF41", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": ".ALPHA.-TOCOPHEROL, DL-", "unii": "7QWA1RIO01", "classCode": "ACTIM", "strengthNumerator": "4.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PYRIDOXINE", "unii": "KV2JZ1BI6Z", "classCode": "ACTIM", "strengthNumerator": "26", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BIOTIN", "unii": "6SO6U10H04", "classCode": "ACTIB", "strengthNumerator": "0.28", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FOLIC ACID", "unii": "935E97BOY8", "classCode": "ACTIB", "strengthNumerator": "1.67", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CYANOCOBALAMIN", "unii": "P6YC3EG204", "classCode": "ACTIB", "strengthNumerator": "0.013", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIM", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIM", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FERROUS CATION", "unii": "GW89581OWR", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "IODIDE ION", "unii": "09G4I6V86Q", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "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", "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.", "HOW SUPPLIED": "Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.", "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.", "CONTRAINDICATIONS": "Folaten is contraindicated in patients with a known hypersensitivity to any of the ingredients.", "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": "One tablet daily or as directed by a physician."}