{ "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": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Vitafol One Prenatal Supplement with DHA SORBITOL GLYCERIN SOYBEAN OIL WATER YELLOW WAX LECITHIN, SOYBEAN TITANIUM DIOXIDE GELATIN, UNSPECIFIED SUNFLOWER OIL FD&C BLUE NO. 1 VITAMIN A VITAMIN A ASCORBIC ACID ASCORBIC ACID THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACIN NIACIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN FOLIC ACID FOLIC ACID IODINE IODINE MAGNESIUM MAGNESIUM ZINC ZINC COPPER COPPER VITAMIN D CHOLECALCIFEROL OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL IRON IRON ETHYL VANILLIN MICROCRYSTALLINE CELLULOSE MANNITOL Dark Blue size 12 Oval Capsule EV0070" ], "spl_unclassified_section": [ "Vitafol One ® Prenatal Supplement with DHA Rx", "*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.", "Rx Distributed by: Exeltis USA, Inc. Florham Park, NJ 07932 1-877-324-9349 www.exeltisusa.com ©2025 Exeltis USA, Inc. All rights reserved. U.S. Patent No. 8,183,227 Vitafol ® is a trademark of Exeltis Healthcare S.L. Rev. January 2025 0703001-05" ], "description": [ "COMPOSITION: Each Softgel Capsule Contains: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 330 mcg RAE Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 25 mcg Vitamin E (as dl-alpha tocopheryl acetate) 9 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as polysaccharide iron complex) 29 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 20 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Docosahexaenoic acid (DHA) (from natural algal oil) 200 mg Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide. Contains: Soy." ], "description_table": [ "
Each Softgel Capsule Contains:
VITAMINS AND MINERALS:
Vitamin A (as beta carotene)330 mcg RAE
Vitamin C (as ascorbic acid)30 mg
Vitamin D (as cholecalciferol)25 mcg
Vitamin E (as dl-alpha tocopheryl acetate)9 mg
Thiamin (Vitamin B1 as thiamine mononitrate)1.6 mg
Riboflavin (Vitamin B2)1.8 mg
Niacin (as niacinamide)15 mg NE
Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
Folate (as folic acid)1700 mcg DFE
Vitamin B12 (as cyanocobalamin)12 mcg
Iron (as polysaccharide iron complex)29 mg
Iodine (as potassium iodide)150 mcg
Magnesium (as magnesium oxide)20 mg
Zinc (as zinc oxide)25 mg
Copper (as copper oxide)2 mg
Docosahexaenoic acid (DHA)(from natural algal oil)200 mg
" ], "indications_and_usage": [ "USAGE: Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.*" ], "contraindications": [ "CONTRAINDICATIONS: Vitafol ® One is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12)." ], "boxed_warning": [ "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately." ], "warnings": [ "WARNINGS/PRECAUTIONS: Vitafol ® One should be used with caution in patients with known sensitivity or allergy to soy. Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Iodine should be used with caution in patients with an overactive thyroid. Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage. Keep out of the reach of children. Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin drug interactions. Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. Pediatric Use: Not recommended for pediatric use." ], "drug_interactions": [ "Drug Interactions: Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism. Medications for hypertension used in conjunction with iodine supplementation may increase potassium. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin drug interactions." ], "information_for_patients": [ "Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding." ], "pediatric_use": [ "Pediatric Use: Not recommended for pediatric use." ], "adverse_reactions": [ "ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® One. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems. You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by a physician." ], "how_supplied": [ "HOW SUPPLIED: Vitafol ® One is available as dark a blue, oval shaped softgel capsule imprinted “EV0070”. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (0642-0070-30) and as professional samples (0642-0070-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture." ], "storage_and_handling": [ "Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture." ], "spl_unclassified_section_table": [ "
*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.
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton 0642-0070-30 VITAFOL One Prenatal Supplement with DHA Unit Dose Pack 30 Softgel Capsules R X DIETARY SUPPLEMENT U.S. PATENTED Vitafol One" ], "set_id": "42a5cafd-a2c0-4ac2-99c9-708642f00716", "id": "30c98709-e351-f96b-e063-6394a90a9eb5", "effective_time": "20250320", "version": "5", "openfda": { "brand_name": [ "Vitafol One" ], "generic_name": [ "PRENATAL SUPPLEMENT WITH DHA" ], "manufacturer_name": [ "Exeltis USA, Inc." ], "product_ndc": [ "0642-0070" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL", "ASCORBIC ACID", "COPPER", "CYANOCOBALAMIN", "FOLIC ACID", "IODINE", "IRON", "MAGNESIUM", "NIACIN", "OMEGA-3 FATTY ACIDS", "PYRIDOXINE HYDROCHLORIDE", "RIBOFLAVIN", "THIAMINE MONONITRATE", "VITAMIN A", "VITAMIN D", "ZINC" ], "rxcui": [ "1119569", "1119573" ], "spl_id": [ "30c98709-e351-f96b-e063-6394a90a9eb5" ], "spl_set_id": [ "42a5cafd-a2c0-4ac2-99c9-708642f00716" ], "package_ndc": [ "0642-0070-30", "0642-0070-01", "0642-0070-03" ], "is_original_packager": [ true ], "upc": [ "0306420070303" ], "nui": [ "N0000193618", "M0001797", "M0005152", "N0000175831", "N0000008595", "N0000008924", "N0000175830", "M0022794", "N0000175951", "N0000175594", "M0014839", "M0023885", "N0000175583", "M0022788", "N0000175950" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Copper-containing Intrauterine Device [EPC]", "Vitamin B12 [EPC]", "Nicotinic Acid [EPC]", "Omega-3 Fatty Acid [EPC]", "Vitamin A [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Copper [CS]", "Vitamin B 12 [CS]", "Nicotinic Acids [CS]", "Fatty Acids, Omega-3 [CS]", "Vitamin A [CS]" ], "pharm_class_pe": [ "Decreased Embryonic Implantation [PE]", "Decreased Sperm Motility [PE]", "Inhibit Ovum Fertilization [PE]" ], "unii": [ "H4N855PNZ1", "PQ6CK8PD0R", "789U1901C5", "P6YC3EG204", "935E97BOY8", "9679TC07X4", "E1UOL152H7", "I38ZP9992A", "2679MF687A", "71M78END5S", "68Y4CF58BV", "TLM2976OFR", "8K0I04919X", "81G40H8B0T", "9VU1KI44GP", "J41CSQ7QDS" ] } } ] }