VITAMEDMD ONE RX (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, 5-METHYLTETRAHYDROFOLIC ACID, FOLIC

VITAMEDMD ONE RX (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, 5-METHYLTETRAHYDROFOLIC ACID, FOLIC
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NDC 10782-101-30
Set ID c321dba6-eae6-42fa-8ff9-bdfa6ffabcd9
Category DIETARY SUPPLEMENT
Packager vitaMedMD
Generic Name
Product Class
Product Number
Application Number
  • DESCRIPTION

    vitaMedMD™ One Rx is a prescription prenatal/postnatal dietary supplement containing vitamins, minerals and vegetarian DHA within a purple, opaque softgel.

  • Supplement Facts

    Serving Size: 1 Softgel

    MULTIVITAMIN/MULTIMINERALAmount per softgel% Daily Value Pregnant and Nursing Women
    *
    % Daily Value Not Established
    Vitamin C (as ascorbic acid)60 mg100%
    Vitamin D3 (as cholecalciferol)400 IU100%
    Vitamin E (as dl-alpha tocopheryl acetate)21 IU70%
    Vitamin B1 (as thiamine mononitrate)1.5 mg88%
    Vitamin B2 (as riboflavin)1.7 mg85%
    Vitamin B3 (as niacinamide)20 mg100%
    Vitamin B6 (as pyridoxine HCI)25 mg1000%
    Folate1 mg125%
      Quatrefolic®((6S)-5-methyltetrahydrofolic
      acid, glucosamine salt)        600 mcg
      Folic acid                               400 mcg
    Vitamin B12 (as cyanocobalamin)8 mcg100%
    Biotin (as d-Biotin)300 mcg100%
    Pantothenic Acid (as d-calcium pantothenate)10 mg100%
    Iron (as ferrous fumerate)30 mg167%
    Zinc (as zinc oxide)7.5 mg50%
    DHA (docosahexaenoic acid from algal oil)200 mg*
  • OTHER INGREDIENTS

    Gelatin capsule (gelatin, purified water, vegetable glycerin), high oleic sunflower oil, beeswax, glycerol monostearate, soybean lecithin, purified water, titanium dioxide, sunflower lecithin, rosemary extract, tocopherols and ascorbyl palmitate, D&C Red #33, FD&C Red #40, FD&C Blue #1, orange essential oil.

  • INDICATIONS

    vitaMedMD™ One Rx is a dietary supplement with DHA indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. vitaMedMD™ One Rx can also be beneficial in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

    This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

  • 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 poison control center immediately.
  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

  • WARNING

    Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE AND ADMINISTRATION

    As a dietary supplement, take one softgel daily with a meal. For adults only. Consult your doctor before taking any supplement.

  • HOW SUPPLIED

    Unit dose box of 30 softgels
    Product Code 10782-101-30

  • SAFE HANDLING WARNING

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

  • STATEMENT OF IDENTITY

    Marketed and Distributed by: TherapeuticsMD
    951 Broken Sound Parkway NW, #320, Boca Raton, Florida 33487
    800.728.0009 www.TherapeuticsMD.com

    Quatrefolic® is a registered trademark of Gnosis Spa.
    U.S. Patent No. 7,947,662; and other patents pending.

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Carton

    Product Code 10782-101-30

    vitaMedMD

    One Rx WITH Quatrefolic®

    Prenatal Multivitamin
    with DHA

    14 Vitamins, Minerals and
    200 mg of Plant-based life'sDHA™

    DOCTOR-RECOMMENDED
    for women planning a pregnancy,
    pregnant or nursing

    TherapeuticsMD

    30 SOFTGELS
    DIETARY SUPPLEMENT

    PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VITAMEDMD ONE RX 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, 5-methyltetrahydrofolic acid, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, zinc oxide, and doconexent capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10782-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid60 mg
    cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol400 [iU]
    .alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01) .alpha.-tocopherol acetate, dl-21 [iU]
    thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J) thiamine mononitrate1.5 mg
    riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin1.7 mg
    niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide20 mg
    pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine hydrochloride25 mg
    5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F) 5-METHYLTETRAHYDROFOLIC ACID600 ug
    folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid400 ug
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin8 ug
    biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin300 ug
    calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737) calcium pantothenate10 mg
    ferrous fumarate (UNII: R5L488RY0Q) (ferrous cation - UNII:GW89581OWR) ferrous fumarate30 mg
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide7.5 mg
    doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC) doconexent200 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin (UNII: 2G86QN327L)  
    water (UNII: 059QF0KO0R)  
    yellow wax (UNII: 2ZA36H0S2V)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    tocopherol (UNII: R0ZB2556P8)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Rosemary (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:10782-101-3030 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/15/2012
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)23 mm
    Labeler - vitaMedMD (019920270)
    Establishment
    NameAddressID/FEIBusiness Operations
    vitaMedMD019920270MANUFACTURE(10782-101)