ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol (R) Ultra. 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 serious adverse event or obtain product information, contact 1-877-324-9349.

BOXED WARNING SECTION.

Warning. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or Poison Control Center immediately.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Vitafol (R) Ultra 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 B12).

DESCRIPTION SECTION.

COMPOSITION. Amount per Capsule:VITAMINS AND MINERALS:Vitamin (as beta carotene)330 mcg RAEVitamin (as ascorbic acid)30 mgVitamin (as cholecalciferol)25 mcgVitamin (as dl-alpha tocopheryl acetate)9 mgThiamin (Vitamin B1 as thiamine mononitrate)1.6 mgRiboflavin (Vitamin B2)1.8 mgNiacin (as niacinamide)15 mg NEVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolate (680 mcg DFE from folic acid 1020 mcg DFE from l-methylfolate calcium) 1700 mcg DFEVitamin B12 (as cyanocobalamin)12 mcgIron (as polysaccharide iron complex)29 mgIodine (as potassium iodide)150 mcgMagnesium (as magnesium oxide)20 mgZinc (as zinc oxide)25 mgCopper (as copper oxide)2 mgDocosahexaenoic acid (DHA)(from natural algal oil)200 mgOther Ingredients:Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Microcrystalline Cellulose, Mannitol, FD&C Blue 1, Ethyl Vanillin. Titanium Dioxide (color). May contain: Sunflower Oil, Olive Oil.Contains: Soy.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Before, during and after pregnancy, take one softgel capsule by mouth daily, or as directed by physician.

DRUG INTERACTIONS SECTION.

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 patients response to methotrexate.Vitamin 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 hours apart to minimize interactions.Consult appropriate references for additional specific vitamin-drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Vitafol (R) Ultra is available as dark blue, oval shaped softgel capsule imprinted EV0093. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of softgel capsules) (0642-0093-30) and as professional samples (0642- 0093-03). Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat and moisture.

INDICATIONS & USAGE SECTION.

USAGE. Vitafol (R) Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother. Vitafol (R) Ultra does not contain fish, fish oils, fish proteins or fish byproducts.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Capsule Blister Pack Box. 0642-0093-30V (R) VITAFOL ULTRA Prenatal Supplement with 200mg DHA Unit Dose Pack 30 Softgel Capsules x DIETARY SUPPLEMENT U.S. PATENTED Vitafol Ultra.

SPL UNCLASSIFIED SECTION.

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.RxDistributed by: Exeltis USA, Inc. Florham Park, NJ 07932 1-877-324-9349 www.exeltisusa.com (C)2024 Exeltis USA, Inc. All rights reserved. Vitafol (R) is trademark of Exeltis Healthcare S.L. U.S. Patent No. 8,183,227 Rev. July 20240933001-04.

STORAGE AND HANDLING SECTION.

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat and moisture.

WARNINGS SECTION.

WARNINGS/PRECAUTIONS. Vitafol (R) Ultra contains soy and should be used with caution in patients with known sensitivity or allergy to soy. Vitamin 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 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 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.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 patients response to methotrexate.Vitamin 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 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.