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

  • NDC Code(s): 0642-0070-01, 0642-0070-30
  • Packager: Everett Laboratories, 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 16, 2021

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

  • SPL UNCLASSIFIED SECTION

    Rx

    0642-0070-30

  • DESCRIPTION

    *
    providing 200DHA (docosahexaenoic acid)
    COMPOSITION:
    Each Softgel Capsule Contains:
    VITAMINS AND MINERALS:
    Vitamin A (as Vitamin A palmitate)330 mcg RAE
    Vitamin C (as ascorbic acid)30 mg
    Vitamin D3 (as cholecalciferol)25 mcg
    Vitamin E (as dl-alpha tocopheryl acetate)9 mg
    Thiamine mononitrate (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 (as folic acid)1700 mcg DFE
    Vitamin B12 (as cyanocobalamin)12 mcg
    Elemental 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, USP Purified Water, Yellow Beeswax, Dicalcium Phosphate, Soy Lecithin, Vegetable Oil, FD&C Blue #1, Titanium Dioxide (color), Sodium Thiosulfate, Caramel (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate. Contains: Soy.

  • INDICATIONS AND 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. Vitafol-One does not contain fish, fish oils, fish proteins or fish byproducts.

  • 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.

  • DOSAGE AND ADMINISTRATION

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

  • HOW SUPPLIED

    Vitafol-One is available as a dark 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 and moisture.

  • SPL UNCLASSIFIED SECTION

    Rx

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

    1-877-324-9349
    www.exeltisusa.com
    ©2019 Exeltis USA, Inc.

    U.S. Patent No. 8,183,227
    Vitafol® is a trademark of Exeltis USA, Inc.

    Rev. April 2021
    0703001-02

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton

    0642-0070-30

    VITAFOL
    One

    Prenatal Supplement with DHA

    Unit Dose Pack
    30 Softgel Capsules

    RX
    DIETARY SUPPLEMENT
    U.S. PATENTED

    PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton
  • 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) Cyanocobalamin.012 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1700 ug
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine0.150 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
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Soybean Oil (UNII: 241ATL177A)  
    Water (UNII: 059QF0KO0R)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sodium Thiosulfate (UNII: HX1032V43M)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbyl palmitate (UNII: QN83US2B0N)  
    Caramel (UNII: T9D99G2B1R)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Corn Oil (UNII: 8470G57WFM)  
    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 BOX06/13/2011
    24 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 - Everett Laboratories, Inc. (071170534)