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) Fe+. 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) Fe+ prenatal supplement 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 supplementation 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. Each PURPLE softgel capsule contains:Vitamin (as beta carotene)330 mcg RAEVitamin (as ascorbic acid)60 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 mgFolate1700 mcg DFE (as Folic acid USP 680 mcg DFE; as L-methylfolate calcium 1020 mcg DFE)Vitamin B12 (as cyanocobalamin)25 mgIron (as polysaccharide iron complex)90 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, Soybean Oil, Sorbitol, Glycerin, Yellow Beeswax, USP Purified Water, Lecithin, Titanium Dioxide (as colorant), FD&C Red 40, FD&C Blue 1, White Edible Ink.Contains: Soy. May also contain: Corn Oil, DL alpha-tocopherol, Medium ChainTriglycerides.

DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS FOR USE. Take one purple softgel capsule daily during pregnancy, 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 levels in blood.High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Vitafol(R) Fe+ is available as purple, oval shaped softgel capsule imprinted EX0096. Available in box of Unit-Dose pack of 30 (5 child resistant blister cards containing softgel capsules), Item No. 0642-7473-30 and as professional sample Item No. 0642-7473-01 (blister card containing softgel capsules). Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat above 30C (86F), light and moisture.Please dispose of any unused capsules promptly, and properly.

INDICATIONS & USAGE SECTION.

USAGE. Vitafol(R) Fe+ prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish. Vitafol(R) Fe+does not contain fish oils, fish proteins, or fish by-products.

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 Dose Pack Box. 0642-7473-30VITAFOL Fe+Complete Prenatal Supplement with 90mg ironUnit Dose Pack 30 Softgel CapsulesRX DIETARY SUPPLEMENT U.S. Patent Pending. PRINCIPAL DISPLAY PANEL 30 Capsule Dose Pack Box.

PEDIATRIC USE SECTION.

PEDIATRIC USE. Not for pediatric use.

SPL UNCLASSIFIED SECTION.

You should call your doctor for medical advice about adverse or unexpected reactions. To report to the company an adverse event or obtain product information, call 1-877-324-9349.Distributed by: Exeltis USA, Inc. Florham Park, NJ 07932 1-877-324-9349 www.exeltisusa.com (C)2021 Exeltis USA, Inc.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.Vitafol(R) is trademark of Exeltis USA, Inc. Metafolin(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 7,674,490Issed: April 20214733001-03.

STORAGE AND HANDLING SECTION.

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat above 30C (86F), light and moisture.Please dispose of any unused capsules promptly, and properly.

WARNINGS SECTION.

WARNINGS/PRECAUTIONS. This product is intended for use as directed by your healthcare provider. Do not share with others. Vitafol(R) Fe+ must 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 levels in blood.High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, 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.. 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 for pediatric use.