VITAFOL ULTRA (DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBA

VITAFOL ULTRA (DOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBA
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NDC 0642-0093-01, 0642-0093-03, 0642-0093-30
Set ID 40fa2c3a-f41f-434c-91de-5150a18d3e4b
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Exeltis USA, Inc.
Generic Name
Product Class
Product Number
Application Number
  • COMPOSITION

    Amount per Capsule:

    VITAMINS AND MINERALS:
    *
    (providing 200 mg DHA (docosahexaenoic acid))
    Vitamin A (as beta carotene)330 mcg DFE
    Vitamin C (as ascorbic acid)30 mg
    Vitamin D (as cholecalciferol)25 mcg
    Vitamin E (as dl-alpha tocopheryl acetate)9 mg
    Thiamin (Vitamin B1)1.6 mg
    Riboflavin (Vitamin B2)1.8 mg
    Niacin (as niacinamide)15 mg NE
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
    Folate
    (680 mcg DFE from Folic Acid & 1020 mcg DFE from L-Methylfolate calcium)
    1700 mcg DFE
    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 Natural Algal Oil)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.

  • 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.

  • 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).

  • 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 reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

  • WARNINGS/PRECAUTIONS

    Vitafol®-Ultra contains soy and should be used with caution in patients with known sensitivity or allergy to soy.

    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 (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 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.

  • 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.

  • DIRECTIONS FOR USE

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

  • 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- 0093-03

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

  • SPL UNCLASSIFIED SECTION

    Rx

    Distributed by:
    Exeltis USA, Inc.
    Florham Park, NJ 07932

    1-877-324-9349
    www.exeltisusa.com
    ©2020 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

    Metafolin® is a 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 7,674,490

    Rev. December 2020

    0933001-02

  • PRINCIPAL DISPLAY PANEL - 30 Capsule 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 Capsule Blister Pack Box
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0093
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent200 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide15 mg
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL-9 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol25 ug
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE330 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid30 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
    Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation2 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion150 ug
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Oxide20 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid680 ug
    Levomefolate Calcium (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) Levomefolate Calcium1020 ug
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code EV0093
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0093-305 in 1 BOX09/23/2013
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0642-0093-011 in 1 BOX09/23/201309/23/2013
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0642-0093-031 in 1 BOX09/23/2013
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER09/23/2013
    Labeler - Exeltis USA, Inc. (071170534)