{"dosage_and_administration":["Doseage and Administration Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner."],"effective_time":"20250516","id":"9a9099c2-4b67-4e39-9bd3-924ae7a4e667","openfda":{"brand_name":["Cobalefol"],"generic_name":["VITAMIN"],"is_original_packager":[true],"manufacturer_name":["V2 Pharma LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","N0000010217","N0000175540","N0000009801"],"package_ndc":["72835-550-01"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin D [CS]"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin D [EPC]","Photoenhancer [EPC]"],"pharm_class_moa":["Photoabsorption [MoA]"],"pharm_class_pe":["Photosensitizing Activity [PE]"],"product_ndc":["72835-550"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["9a9099c2-4b67-4e39-9bd3-924ae7a4e667"],"spl_set_id":["7d409065-112d-4bc7-bae6-d558aeb7c0e4"],"substance_name":["ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL SUCCINATE, D-","THIAMINE MONONITRATE","RIBOFLAVIN 5'-PHOSPHATE","NIACINAMIDE","PYRIDOXINE HCL","FOLIC ACID","METHYLCOBALAMIN"],"unii":["PQ6CK8PD0R","1C6V77QF41","LU4B53JYVE","8K0I04919X","7N464URE7E","25X51I8RD4","68Y4CF58BV","935E97BOY8","BR1SN1JS2W"]},"package_label_principal_display_panel":["Cobalefol Label Cobalefol Label"],"precautions":["Contraindications Cobalefol is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner. Precaution Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Cobalefol should only be used under the direction and supervision of a licensed medical practitioner."],"safe_handling_warning":["Storage and Handling Store at room temperature. Avoid excessive heat, light, and moisture. Statements These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. How Supplied Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01 Manufactured for: V2 Pharma, LLC 103 W Main Street Hudson, MI 49247"],"set_id":"7d409065-112d-4bc7-bae6-d558aeb7c0e4","spl_product_data_elements":["Cobalefol VITAMIN ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL SUCCINATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE MONONITRATE THIAMINE ION THIAMINE MONONITRATE RIBOFLAVIN 5'-PHOSPHATE FLAVIN MONONUCLEOTIDE NIACINAMIDE NIACINAMIDE PYRIDOXINE HCL PYRIDOXINE FOLIC ACID FOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED"],"statement_of_identity":["Supplement Facts Cobalefol Capsules - Vitamins dispensed by prescription Supplement Facts Serving Size: 1 Capsule Servings Per Bottle: 30 Ingredients Amount Per Serving %DV Vitamin C (as Ascorbic Acid) 90 mg 100% Vitamin D3 (as Cholecalciferol) 20 mcg 100% Vitamin E (as d-Alpha Tocopheryl Succinate) 10.05 mg 67% Thiamine (as Thiamine Mononitrate) 1.4 mg 116% Riboflavin (as Riboflavin 5 Phosphate) 1.6 mg 123% Niacin (as Niacinamide) 16.3 mg 101% Vitamin B-6 (as Pyridoxine HCl) 2.5 mg 147% Folate (from 1000 mcg Folic Acid) 1700 mcg DFE 425% Vitamin B-12 (as Methylcobalamin) 10 mcg 416% Other ingredients : Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)","Description: Cobalefol is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Cobalefol provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet."],"statement_of_identity_table":["
Ingredients Amount Per Serving%DV
Vitamin C (as Ascorbic Acid) 90 mg 100%
Vitamin D3 (as Cholecalciferol) 20 mcg 100%
Vitamin E (as d-Alpha Tocopheryl Succinate) 10.05 mg 67%
Thiamine (as Thiamine Mononitrate) 1.4 mg 116%
Riboflavin (as Riboflavin 5 Phosphate) 1.6 mg 123%
Niacin (as Niacinamide) 16.3 mg 101%
Vitamin B-6 (as Pyridoxine HCl) 2.5 mg 147%
Folate (from 1000 mcg Folic Acid) 1700 mcg DFE 425%
Vitamin B-12 (as Methylcobalamin) 10 mcg 416%
"],"version":"1","warnings":["WARNINGS KEEP COBALEFOL OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a licensed medical practitioner or poison control center immediately. For use under the supervision of a licensed medical practitioner. Consult your physician prior to using Cobalefol if you are pregnant, nursing, taking medication, or have a medical condition."]}