Label: VITAMEDMD RX PLUS- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, copper, and doconexent

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 21, 2012

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

  • DESCRIPTION

    vitaMedMD™ Plus Rx is a prescription prenatal/postnatal dietary supplement containing a solid white multivitamin tablet and a red opaque softgel.

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  • Supplement Facts

    Serving Size: 1 Tablet

    MULTIVITAMIN/MULTIMINERAL Amount per Tablet % Daily Value Pregnant and Nursing Women
    Vitamin C (as ascorbic acid) 60 mg 100%
    Vitamin D3 (as cholecalciferol) 600 IU 150%
    Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100%
    Vitamin B1 (as thiamine mononitrate) 3 mg 176%
    Vitamin B2 (as riboflavin 5 phosphate sodium) 3.4 mg 170%
    Vitamin B3 (as niacinamide) 20 mg 100%
    Vitamin B6 (as pyridoxine HCl) 25 mg 1000%
    Folate 1 mg 125%
      Quatrefolic®((6S)-5-methyltetrahydrofolic
      acid, glucosamine salt)        600 mcg
      Folic acid                               400 mcg
    Vitamin B12 (as cyanocobalamin) 12 mcg 150%
    Biotin (as d-Biotin) 300 mcg 100%
    Pantothenic Acid (as d-calcium pantothenate) 10 mg 100%
    Calcium (as calcium carbonate) 150 mg 12%
    Iron (as iron amino acid chelate) 30 mg 167%
    Iodine (as potassium iodide) 150 mcg 100%
    Zinc (as zinc amino acid chelate) 15 mg 100%
    Copper (as copper amino acid chelate) 2 mg 100%
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  • OTHER INGREDIENTS

    Microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silicon dioxide, titanium dioxide, hypromellose, inulin, medium chained triglycerides and natural orange flavor.

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  • Supplement Facts

    Serving Size: 1 Softgel

    DHA Amount per Softgel % Daily Value Pregnant and Nursing Women
    *
    % Daily Value Not Established
    Calories 10
    Calories from Fat 10
    Total Fat 1 g 100%
      Polyunsaturated Fat .5 g *
    DHA (docosahexaenoic acid from algal oil) 300 mg *
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  • OTHER INGREDIENTS

    Gelatin capsule (porcine gelatin, glycerin, purified water, carmine, annatto, caramel, titanium dioxide), high oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols and ascorbyl palmitate as antioxidants.

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  • INDICATIONS

    vitaMedMD™ Plus 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™ Plus Rx can also be beneficial in improving the nutritional status of women prior to conception.

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  • CONTRAINDICATIONS

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

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  • 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.
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  • 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.

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  • 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.

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND ADMINISTRATION

    As a dietary supplement for pregnant and nursing women. Take one softgel and one tablet daily with a meal. For adults only. Consult your doctor before taking any supplement.

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  • HOW SUPPLIED

    Unit dose box of 30 softgels + 30 tablets
    Product Code 10782-201-60

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  • SAFE HANDLING WARNING

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

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  • 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.

    PLRX-0008 01/12

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  • PRINCIPAL DISPLAY PANEL - 30 Tablet + 30 Softgel Bottle Carton

    Product Code 10782-201-60

    vitaMedMD

    Plus Rx WITH Quatrefolic®

    Prenatal Multivitamin
    Plus DHA Softgel

    MULTIVITAMIN TABLET
    16 Vitamins and Minerals

    DHA SOFTGEL
    300 mg of Plant-based life'sDHA™

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

    TherapeuticsMD

    30 TABLETS + 30 SOFTGELS
    DIETARY SUPPLEMENT

    PRINCIPAL DISPLAY PANEL - 30 Tablet + 30 Softgel Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    VITAMEDMD   RX PLUS
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, copper, and doconexent kit
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:10782-201
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:10782-201-60 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK 30 
    Part 2 1 BLISTER PACK 30 
    Part 1 of 2
    PRENATAL MULTIVITAMIN 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous bisglycinate hydrochloride, potassium iodide, zinc glycinate, and copper tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid 60 mg
    cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol 600 [iU]
    .alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol, dl- - UNII:7QWA1RIO01) .alpha.-tocopherol acetate, dl- 30 [iU]
    thiamine mononitrate (UNII: 8K0I04919X) (thiamine ion - UNII:4ABT0J945J) thiamine mononitrate 3 mg
    riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin 3.4 mg
    niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide 20 mg
    pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine hydrochloride 25 mg
    folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid 400 ug
    5-methyltetrahydrofolic acid (UNII: TYK22LML8F) (5-methyltetrahydrofolic acid - UNII:TYK22LML8F) 5-methyltetrahydrofolic acid 600 ug
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin 12 ug
    biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin 300 ug
    calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737) calcium pantothenate 10 mg
    calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate 150 mg
    ferrous bisglycinate hydrochloride (UNII: IW3QLZ8MRC) (ferrous cation - UNII:GW89581OWR) ferrous bisglycinate hydrochloride 30 mg
    potassium iodide (UNII: 1C4QK22F9J) (iodide ion - UNII:09G4I6V86Q) potassium iodide 150 ug
    zinc glycinate (UNII: 681VJX72FE) (zinc cation - UNII:13S1S8SF37) zinc glycinate 15 mg
    copper (UNII: 789U1901C5) (copper - UNII:789U1901C5) copper 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    stearic acid (UNII: 4ELV7Z65AP)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    hypromelloses (UNII: 3NXW29V3WO)  
    inulin (UNII: JOS53KRJ01)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 03/01/2012
    Part 2 of 2
    DHA SOFTGEL 
    doconexent capsule, gelatin coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC) doconexent 300 mg
    Inactive Ingredients
    Ingredient Name Strength
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    annatto (UNII: 6PQP1V1B6O)  
    caramel (UNII: T9D99G2B1R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    tocopherol (UNII: R0ZB2556P8)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    sunflower oil (UNII: 3W1JG795YI)  
    rosemary (UNII: IJ67X351P9)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 03/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 03/01/2012
    Labeler - vitaMedMD (019920270)
    Establishment
    Name Address ID/FEI Business Operations
    vitaMedMD 019920270 MANUFACTURE(10782-201)
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