{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Folartex Multivitamin BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE BIOTIN BIOTIN FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION MAGNESIUM OXIDE MAGNESIUM CATION FERROUS BISGLYCINATE FERROUS CATION POTASSIUM IODIDE IODIDE ION CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN CROSCARMELLOSE SODIUM SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE HYDROXYPROPYL METHYLCELLULOSE POLYETHYLENE GLYCOL 1000 TITANIUM DIOXIDE FD&C BLUE NO. 1 tan Oblong" ], "spl_unclassified_section": [ "Folarex" ], "description": [ "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 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 DFE 418% (from Folic Acid) 0.67 mg DFE (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: Microcrysta l ine Ce l ulose, Maltodextrin, Croscarme l ose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce l ulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1" ], "description_table": [ "
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%
" ], "indications_and_usage": [ "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": [ "CONTRAINDICATIONS Folarex is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "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." ], "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, ca l a doctor or poison control center immediately." ], "adverse_reactions": [ "ADVERSE REACTIONS Al l ergic sensitization has been reported fo l owing 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 AND ADMINISTRATION One tablet daily or as directed by a physician." ], "how_supplied": [ "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 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" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL 85477-511-30 Folarex MULTIVITAMIN 30 TABLETS Oncora Pharma, LLC 85477-511-30 Folarex MULTIVITAMIN 30 TABLETS" ], "set_id": "0a4cb0ab-565f-45e8-a989-740bccef21cd", "id": "a9886a49-ba1d-44f5-96e5-26c927d6db9c", "effective_time": "20260225", "version": "1", "openfda": { "brand_name": [ "Folartex" ], "generic_name": [ "MULTIVITAMIN" ], "manufacturer_name": [ "Oncora Pharma, LLC" ], "product_ndc": [ "85477-511" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BETA CAROTENE", "ASCORBIC ACID", "CHOLECALCIFEROL", ".ALPHA.-TOCOPHEROL ACETATE, DL-", "PYRIDOXINE HYDROCHLORIDE", "BIOTIN", "FOLIC ACID", "CYANOCOBALAMIN", "CALCIUM CARBONATE", "MAGNESIUM OXIDE", "FERROUS BISGLYCINATE", "POTASSIUM IODIDE" ], "spl_id": [ "a9886a49-ba1d-44f5-96e5-26c927d6db9c" ], "spl_set_id": [ "0a4cb0ab-565f-45e8-a989-740bccef21cd" ], "package_ndc": [ "85477-511-30" ], "is_original_packager": [ true ], "nui": [ "N0000193618", "M0001797", "M0022797", "N0000175952", "M0022794", "N0000175951" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]" ], "unii": [ "01YAE03M7J", "PQ6CK8PD0R", "1C6V77QF41", "WR1WPI7EW8", "68Y4CF58BV", "6SO6U10H04", "935E97BOY8", "P6YC3EG204", "H0G9379FGK", "3A3U0GI71G", "SFW1D987QV", "1C4QK22F9J" ] } } ] }