VITAFOL GUMMIES (VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, IODINE, CHOLINE, DOCONEXENT, ICOSAPENT, AND OMEGA

VITAFOL GUMMIES (VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, IODINE, CHOLINE, DOCONEXENT, ICOSAPENT, AND OMEGA
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NDC 0642-0125-03, 0642-0125-90
Set ID 2981c1b7-2584-496a-a77e-8ea0594d5065
Category DIETARY SUPPLEMENT
Packager Exeltis USA, Inc.
Generic Name
Product Class
Product Number
Application Number
  • HEALTH CLAIM


    Rx

  • COMPOSITION

    Amount per daily dose (3 gummies)

    VITAMINS AND MINERALS:
    Calories24
    Total Carbohydrates5 g
      Sugars5 g
    Vitamin A (as Vitamin A palmitate)330 mcg RAE
    Vitamin C (as ascorbic acid)30 mg
    Vitamin D (as cholecalciferol)25 mcg
    Vitamin E (as d-alpha tocopheryl acetate)6.75 mg
    Niacin (as niacinamide)15 mg NE
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
    Folate (as folic acid)1700 mcg DFE
    Vitamin B12 (as cyanocobalamin)8 mcg
    Iron (as ferric orthophosphate)10 mg
    Iodine (as potassium iodide)150 mcg
    Choline (as choline bitartrate)10 mg
    Omega 3 fatty acid104.5 mg
      Docosahexaenoic acid (DHA) 75 mg
      Eicosapentaenoic acid (EPA) 15.3 mg
      Other Omega 3 fatty acid 14.2 mg

    Other Ingredients: Sugar, glucose syrup, water, gelatin, lactic acid, citric acid, mixed berry flavor, Certicoat 580 (contains mineral oil and Carnauba wax), Natural Color and Masking flavor.

    Contains soybean and fish oil (cod).

  • USAGE

    Vitafol® Gummies is indicated to provide vitamin, mineral, and DHA supplementation throughout pregnancy.

  • CONTRAINDICATIONS

    Vitafol® Gummies 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

    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. Please do not share with others. Contains soybean and fish oil (cod).

    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.

    Do not use if inner seal is broken or missing.

    Do not exceed recommended dose.

    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.

    Pediatric Use

    Not for pediatric use.

  • ADVERSE REACTIONS

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

    During pregnancy, take 3 gummies once daily, or as directed by a physician.

  • HOW SUPPLIED

    Vitafol® Gummies is available as a coated berry shaped gummy. Available in bottle of 90, Item No. 0642-0125-90 and as professional samples, in bottle with 3 gummies, Item No. 0642-0125-04.

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

    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

  • HEALTH CLAIM

    Made in Colombia.
    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.
    U.S. Patent Pending

    Rev. April 2021
    1250301-04

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    0642-0125-90

    VITAFOL
    gummies

    Prenatal Vital Nutrition with iron

    90 gummies (30 Days Supply)

    RX
    DIETARY SUPPLEMENT

    Principal Display Panel - 90 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    VITAFOL GUMMIES 
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, iodine, choline, doconexent, icosapent, and omega-3 fatty acids tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0642-0125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A330 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid30 mg
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D25 ug
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol6.75 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin15 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1700 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin8 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron10 mg
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine150 ug
    Choline (UNII: N91BDP6H0X) (Choline - UNII:N91BDP6H0X) Choline10 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT75 mg
    Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent15.3 mg
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids14.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    Water (UNII: 059QF0KO0R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Keracyanin (UNII: V0N2VMB4FV)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0642-0125-9090 in 1 BOTTLE, PLASTIC
    2NHRIC:0642-0125-043 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT05/01/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)20 mm
    flavor
    Labeler - Exeltis USA, Inc. (071170534)