{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ® -OB+DHA. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions. Contact your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349."],"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."],"contraindications":["CONTRAINDICATIONS Vitafol ® -OB+DHA 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)."],"description":["COMPOSITION Each Vitafol ® -OB caplet contains: Vitamin A (as beta carotene) 810 mcg RAE Vitamin C (as ascorbic acid) 70 mg Vitamin D (as cholecalciferol) 10 mcg Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 18 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 12 mcg Calcium (as calcium carbonate) 100 mg Iron (as ferrous fumarate) 65 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 25 mg Copper (as copper oxide) 2 mg Each DHA softgel capsule contains: Docosahexaenoic acid (DHA) (from natural algal oil) 250 mg"],"description_table":["
Vitamin A (as beta carotene)810 mcg RAE
Vitamin C (as ascorbic acid)70 mg
Vitamin D (as cholecalciferol)10 mcg
Vitamin E (as dl-alpha tocopheryl acetate)13.5 mg
Thiamin (Vitamin B1 as thiamine mononitrate)1.6 mg
Riboflavin (Vitamin B2)1.8 mg
Niacin (as niacinamide)18 mg NE
Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
Folate (as folic acid)1700 mcg DFE
Vitamin B12 (as cyanocobalamin)12 mcg
Calcium (as calcium carbonate)100 mg
Iron (as ferrous fumarate)65 mg
Magnesium (as magnesium oxide)25 mg
Zinc (as zinc oxide)25 mg
Copper (as copper oxide)2 mg
Each DHA softgel capsule contains:
Docosahexaenoic acid (DHA) (from natural algal oil)250 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one caplet and one soft-gel capsule by mouth daily, or as directed by a physician."],"drug_interactions":["Drug Interactions High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. 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; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions."],"effective_time":"20250320","how_supplied":["HOW SUPPLIED Vitafol ® -OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 caplets and 6 softgel capsules each) (0642-0076-30) and as professional samples (0642-0076-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture."],"id":"30c90d31-b4c5-a517-e063-6394a90a633c","indications_and_usage":["INDICATIONS AND USAGE Vitafol ® -OB+DHA 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.* Vitafol ® -OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts."],"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."],"openfda":{"brand_name":["Vitafol-OB Plus DHA Prenatal Supplement Plus DHA"],"generic_name":["VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, IRON, MAGNESIUM, ZINC, COPPER, AND DOCONEXENT"],"is_original_packager":[true],"manufacturer_name":["Exeltis USA, Inc"],"package_ndc":["0642-0076-30","0642-0076-03"],"product_ndc":["0642-0076"],"product_type":["HUMAN PRESCRIPTION DRUG"],"rxcui":["1100198"],"spl_id":["30c90d31-b4c5-a517-e063-6394a90a633c"],"spl_set_id":["a0e273e2-0876-4830-a903-282085be7f32"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Kit Carton 0642-0076-30 Vitafol ® -OB+DHA Prenatal Supplement with DHA SUGAR, LACTOSE, GLUTEN AND IODINE FREE New Smaller DHA Softgel DOES NOT CONTAIN FISH OIL R X Unit Dose Pack 30 Caplets and 30 Softgel Capsules U.S. Patented Vitafol OB+DHA Carton"],"pediatric_use":["Pediatric Use Not for pediatric use."],"set_id":"a0e273e2-0876-4830-a903-282085be7f32","spl_product_data_elements":["Vitafol-OB Plus DHA Prenatal Supplement Plus DHA Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent Vitafol-OB Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper HYDROXYPROPYL METHYLCELLULOSE COPOVIDONE K25-31 MANNITOL POLYDEXTROSE MALTODEXTRIN SOYBEAN MICROCRYSTALLINE CELLULOSE STEARIC ACID CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) STARCH, CORN TOCOPHEROL MAGNESIUM STEARATE TITANIUM DIOXIDE ACACIA POLYETHYLENE GLYCOL, UNSPECIFIED TRIACETIN FD&C BLUE NO. 1 FD&C BLUE NO. 2 ASCORBIC ACID ASCORBIC ACID VITAMIN D CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACIN NIACIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM IRON IRON MAGNESIUM MAGNESIUM ZINC ZINC COPPER COPPER VITAMIN A VITAMIN A TALC EV0079 DHA DOCONEXENT GLYCERIN GELATIN, UNSPECIFIED WATER DOCONEXENT DOCONEXENT Amber"],"spl_unclassified_section":["Prenatal Supplement with DHA Rx","Other ingredients: gelatin (bovine), gylcerin, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, water, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2. Contains: Soy.","*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 ©2024 Exeltis USA, Inc. U.S. Patent No. 6,814,983; 7,390,509 Vitafol ® is a trademark of Exeltis USA, Inc. Rev. July 2024 0763001-04"],"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.
"],"storage_and_handling":["Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture."],"version":"7","warnings":["WARNINGS/PRECAUTIONS Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathryroidism 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. 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."]}