Label: VITAFOL FE PLUS- 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

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated May 24, 2021

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  • COMPOSITION

    Each PURPLE softgel capsule contains:

    *
    (providing 200 mg DHA (docosahexaenoic acid))
    Vitamin A (as beta carotene)330 mcg RAE
    Vitamin C (as ascorbic acid)60 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
    Folate1700 mcg DFE
      (as Folic acid USP 680 mcg DFE; as L-methylfolate calcium 1020 mcg DFE)
    Vitamin B12 (as cyanocobalamin)25 mg
    Iron (as polysaccharide iron complex)90 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, 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.

  • USAGE

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

  • CONTRAINDICATIONS

    Vitafol® 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).

  • 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

    This product is intended for use as directed by your healthcare provider. Do not share with others. Vitafol® Fe+ must 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 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 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.

    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.

  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol® Fe+. 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

    Take one purple softgel capsule daily during pregnancy, or as directed by a physician.

  • HOW SUPPLIED

    Vitafol® Fe+ is available as a purple, oval shaped softgel capsule imprinted "EX0096". Available in box of Unit-Dose pack of 30 (5 child resistant blister cards containing 6 softgel capsules), Item No. 0642-7473-30 and as professional sample Item No. 0642-7473-01 (blister card containing 3 softgel capsules)

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

    Please dispose of any unused capsules promptly, and properly.

  • 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
    ©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® is a trademark of Exeltis USA, Inc.
    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

    Issed: April 2021

    4733001-03

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Dose Pack Box

    0642-7473-30

    VITAFOL
    Fe+

    Complete Prenatal Supplement
    with 90mg iron

    Unit Dose Pack
    30 Softgel Capsules

    RX
    DIETARY SUPPLEMENT
    U.S. Patent Pending

    PRINCIPAL DISPLAY PANEL - 30 Capsule Dose Pack Box
  • INGREDIENTS AND APPEARANCE
    VITAFOL FE PLUS 
    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:0642-7473
    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 mg
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE330 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 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) CYANOCOBALAMIN25 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron90 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) POTASSIUM IODIDE150 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE20 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid680 mg
    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)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Corn oil (UNII: 8470G57WFM)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code EV0096
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-7473-305 in 1 BOX, UNIT-DOSE03/15/2020
    16 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER03/15/2020
    Labeler - Exeltis USA, Inc. (071170534)