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 kit

  • 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.

  • Supplement Facts

    Serving Size: 1 Tablet

    MULTIVITAMIN/MULTIMINERALAmount per Tablet% Daily Value Pregnant and Nursing Women
    Vitamin C (as ascorbic acid)60 mg100%
    Vitamin D3 (as cholecalciferol)600 IU150%
    Vitamin E (as dl-alpha tocopheryl acetate)30 IU100%
    Vitamin B1 (as thiamine mononitrate)3 mg176%
    Vitamin B2 (as riboflavin 5 phosphate sodium)3.4 mg170%
    Vitamin B3 (as niacinamide)20 mg100%
    Vitamin B6 (as pyridoxine HCl)25 mg1000%
    Folate1 mg125%
      Quatrefolic®((6S)-5-methyltetrahydrofolic
      acid, glucosamine salt)        600 mcg
      Folic acid                               400 mcg
    Vitamin B12 (as cyanocobalamin)12 mcg150%
    Biotin (as d-Biotin)300 mcg100%
    Pantothenic Acid (as d-calcium pantothenate)10 mg100%
    Calcium (as calcium carbonate)150 mg12%
    Iron (as iron amino acid chelate)30 mg167%
    Iodine (as potassium iodide)150 mcg100%
    Zinc (as zinc amino acid chelate)15 mg100%
    Copper (as copper amino acid chelate)2 mg100%
  • OTHER INGREDIENTS

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

  • Supplement Facts

    Serving Size: 1 Softgel

    DHAAmount per Softgel% Daily Value Pregnant and Nursing Women
    *
    % Daily Value Not Established
    Calories10
    Calories from Fat10
    Total Fat1 g100%
      Polyunsaturated Fat.5 g*
    DHA (docosahexaenoic acid from algal oil)300 mg*
  • 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.

  • 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.

  • 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 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.

  • HOW SUPPLIED

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

  • 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.

    PLRX-0008 01/12

  • 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
  • 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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10782-201
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:10782-201-601 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 30 
    Part 21 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 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) cholecalciferol600 [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 mononitrate3 mg
    riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin3.4 mg
    niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide20 mg
    pyridoxine hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine hydrochloride25 mg
    folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid400 ug
    5-methyltetrahydrofolic acid (UNII: TYK22LML8F) (5-methyltetrahydrofolic acid - UNII:TYK22LML8F) 5-methyltetrahydrofolic acid600 ug
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin12 ug
    biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin300 ug
    calcium pantothenate (UNII: 568ET80C3D) (pantothenic acid - UNII:19F5HK2737) calcium pantothenate10 mg
    calcium carbonate (UNII: H0G9379FGK) (calcium cation - UNII:2M83C4R6ZB) calcium carbonate150 mg
    ferrous bisglycinate hydrochloride (UNII: IW3QLZ8MRC) (ferrous cation - UNII:GW89581OWR) ferrous bisglycinate hydrochloride30 mg
    potassium iodide (UNII: 1C4QK22F9J) (iodide ion - UNII:09G4I6V86Q) potassium iodide150 ug
    zinc glycinate (UNII: 681VJX72FE) (zinc cation - UNII:13S1S8SF37) zinc glycinate15 mg
    copper (UNII: 789U1901C5) (copper - UNII:789U1901C5) copper2 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement03/01/2012
    Part 2 of 2
    DHA SOFTGEL 
    doconexent capsule, gelatin coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    doconexent (UNII: ZAD9OKH9JC) (doconexent - UNII:ZAD9OKH9JC) doconexent300 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement03/01/2012
    Labeler - vitaMedMD (019920270)
    Establishment
    NameAddressID/FEIBusiness Operations
    vitaMedMD019920270MANUFACTURE(10782-201)