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.

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 DFEVitamin (as ascorbic acid)30 mgVitamin (as cholecalciferol)25 mcgVitamin (as dl-alpha tocopheryl acetate)9 mgThiamin (Vitamin B1)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 mgAlgal oil blend (derived from Natural Algal Oil)415 mg(providing 200 mg DHA (docosahexaenoic acid)) Other Ingredients:Gelatin (bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, Yellow Beeswax, USP Purified Water, Lecithin, FD&C Blue 1, Titanium Dioxide (color), Ethyl Vanillin. May contain: Corn Oil, dl-alpha tocopherol, High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate.Contains: Soy.

DOSAGE & ADMINISTRATION SECTION.


DIRECTIONS FOR USE. Before, during and after pregnancy, one softgel capsule 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, including individuals with known allergies to fish. 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) VITAFOLULTRAPrenatal Supplement with 200mg DHAUnit Dose Pack30 Softgel CapsulesRx DIETARY SUPPLEMENTU.S. PATENTED. PRINCIPAL DISPLAY PANEL 30 Capsule Blister Pack Box.

SPL UNCLASSIFIED SECTION.


RxDistributed by:Exeltis USA, Inc.Florham Park, NJ 079321-877-324-9349www.exeltisusa.com(C)2020 Exeltis USA, Inc.You should call your doctor for medical advice about serious adverse events. To report serious adverse event or obtain product information, contact 1-877-324-9349Vitafol(R) is trademark of Exeltis USA, Inc.U.S. Patent No. 8,183,227Metafolin(R) is trademark of Merck KGaA, Darmstadt, Germany.U.S. Patent No. 6,441,168; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490Rev. December 20200933001-02.

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.Consumption of more than 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 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 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.