Label: VITAFOL ONE- prenatal supplement with dha capsule, gelatin coated

  • NDC Code(s): 0642-0070-01, 0642-0070-03, 0642-0070-30
  • Packager: Exeltis USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 20, 2025

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  • SPL UNCLASSIFIED SECTION

    Vitafol One ®
    Prenatal Supplement with DHA
    Rx

  • COMPOSITION:

    Each Softgel Capsule Contains:
    VITAMINS AND MINERALS:
    Vitamin A (as beta carotene)330 mcg RAE
    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 as thiamine mononitrate)1.6 mg
    Riboflavin (Vitamin B2)1.8 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)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

    Docosahexaenoic acid (DHA)

    (from natural algal oil)

    200 mg

    Other Ingredients: Gelatin (Bovine), Glycerin, Soybean Oil, Yellow Beeswax, Sorbitol, Purified Water, Soy Lecithin, Sunflower Oil, Microcrystalline Cellulose, FD&C Blue #1, Ethyl Vanillin, Mannitol, Titanium Dioxide.

    Contains: Soy.

  • USAGE:

    Vitafol ® One is indicated to provide vitamin, mineral, and omega-3 fatty acid 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.*

  • CONTRAINDICATIONS:

    Vitafol ® One 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 B-12).

  • 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 ® One 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; taken 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 recommended 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 ® One. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

    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.

  • DOSAGE AND ADMINISTRATION:

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

  • HOW SUPPLIED:

    Vitafol ® One is available as dark a blue, oval shaped softgel capsule imprinted “EV0070”. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (0642-0070-30) and as professional samples (0642-0070-03).

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

  • SPL UNCLASSIFIED SECTION

    *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.

  • SPL UNCLASSIFIED SECTION

    Rx

    Distributed by:

    Exeltis USA, Inc.

    Florham Park, NJ 07932


    1-877-324-9349

    www.exeltisusa.com

    ©2025 Exeltis USA, Inc. All rights reserved.

    U.S. Patent No. 8,183,227

    Vitafol ® is a trademark of Exeltis Healthcare S.L.

    Rev. January 2025 0703001-05

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton

    0642-0070-30

    VITAFOL

    One

    Prenatal Supplement with DHA

    Unit Dose Pack

    30 Softgel Capsules

    R X

    DIETARY SUPPLEMENT

    U.S. PATENTED

    Vitafol One

  • INGREDIENTS AND APPEARANCE
    VITAFOL  ONE
    prenatal supplement with dha capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0070
    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
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.6 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.8 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.5 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.012 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1700 ug
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.15 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM20 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D25 ug
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS200 mg
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL9 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorblue (Dark Blue) Scoreno score
    ShapeOVAL (size 12 Oval Capsule) Size10mm
    FlavorImprint Code EV0070
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0070-305 in 1 BOX06/13/2011
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0642-0070-011 in 1 BOX06/13/201110/31/2020
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0642-0070-031 in 1 BOX10/01/2018
    33 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2011
    Labeler - Exeltis USA, Inc. (071170534)
    Registrant - Exeltis USA, Inc. (071170534)