Label: VITAFOL ULTRA- doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, .beta.-carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium capsule, liquid filled

  • NDC Code(s): 0642-0093-01, 0642-0093-30
  • Packager: Exeltis USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 4, 2017

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    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.

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  • SPL UNCLASSIFIED SECTION

    Rx

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  • COMPOSITION

    Amount per Capsule:

    VITAMINS AND MINERALS:
    *
    (providing 200 mg DHA (docosahexaenoic acid))
    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*

    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.

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  • 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.

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  • 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).

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  • 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.

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  • 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.

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  • DIRECTIONS FOR USE

    Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

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  • 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°-30°C (59°-86°F), avoid excessive heat, light and moisture.

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  • 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

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  • 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

    PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Box
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  • INGREDIENTS AND APPEARANCE
    VITAFOL   ULTRA
    doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, .beta.-carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium capsule, liquid filled
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0093
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 200 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 15 mg
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL- 20 [iU]
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 1000 [iU]
    .Beta.-Carotene (UNII: 01YAE03M7J) (.Beta.-Carotene - UNII:01YAE03M7J) .Beta.-Carotene 1100 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 30 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 29 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 25 mg
    Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation 2 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion 150 ug
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Oxide 20 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.4 mg
    Levomefolate Calcium (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) Levomefolate Calcium 0.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Soybean Oil (UNII: 241ATL177A)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Ethyl Vanillin (UNII: YC9ST449YJ)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Corn Oil (UNII: 8470G57WFM)  
    .Alpha.-Tocopherol, DL- (UNII: 7QWA1RIO01)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code EV0093
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0642-0093-30 5 in 1 BOX 09/23/2013
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0642-0093-01 1 in 1 BOX 09/23/2013
    2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 09/23/2013
    Labeler - Exeltis USA, Inc. (071170534)
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