BOXED WARNING SECTION.
Warning Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Box 0642-0093-30 V VITAFOL ULTRA Prenatal Supplement with 200mg DHA Unit Dose Pack 30 Softgel Capsules RX DIETARY SUPPLEMENT U.S. PATENTED
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-Ultra. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
INDICATIONS & USAGE SECTION.
USAGE Vitafol-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-Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
DOSAGE & ADMINISTRATION SECTION.
DIRECTIONS FOR USE Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.
SPL UNCLASSIFIED SECTION.
Rx Manufactured for Exeltis USA, Inc. Florham Park, NJ 07932 1-877-324-9349 www.exeltisUSA.com @2015 Exeltis USa, Inc. 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 Vitafol is a trademark of Exeltis USA, Inc. U.S. Patent No. 8,183,227 Life's DHA is a trademark of DSM. U.S. Patent No. 7,163,811 and 7,824,892 Metafolin is a trademark of Merck KGaA, Darmstadt, Germany. U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725 and 7,674,490 Rev. October 2015
HOW SUPPLIED SECTION.
HOW SUPPLIED Vitafol-Ultra is available as a dark blue, oval shaped softgel capsule imprinted "EV0093". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), 0642-0093-30 and as professional samples, 0642-0093-01 Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat, light and moisture.
COMPOSITION Amount per Capsule: VITAMINS AND MINERALS: Vitamin A (as beta carotene) 1100 IU Vitamin C (as ascorbic acid) 30 mg Vitamin D (as cholecalciferol) 1000 IU Vitamin E (as dl-alpha tocopheryl acetate) 20 IU Thiamin (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as Folic acid USP 0.4 mg and L-methylfolate Calcium 0.6 mg, as Metafolin CAS# 151533-22-1) 1 mg 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 Algal oil blend (derived from crypthecodinium cohnii, CAS# 1258273-84-5) 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.
CONTRAINDICATIONS Vitafol-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).
WARNINGS/PRECAUTIONS Vitafol-Ultra contains soy and lactose and should be used with caution in patients with known sensitivity or allergy to soy or lactose. 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 (antithyroid 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; take 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.