Label: TALIVA- folic acid, pyridoxine hydrochloride, cyanocobalamin, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol capsule, gelatin coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated January 5, 2018

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  • HEALTH CLAIM

    Rx Only

  • DESCRIPTION

    TALIVA is a prescription multi-vitamin in the form of a red, opaque softgel.

  • INDICATION AND USAGE

    TALIVA is a prescription multi-vitamin supplement with DHA and EPA that can be taken to improve nutritional status in conditions requiring Essential Fatty Acid, Vitamin B12 and B6 and Folic Acid supplementation capsule.

  • CONTRAINDICATIONS

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

  • WARNING

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

    Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including 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 bleeding diathesis.

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

  • PRECAUTIONS

    Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

  • ADVERSE REACTIONS

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

  • DOSAGE AND ADMINISTRATION

    Adults

    One to four softgels orally daily or as directed by a physician.

    Supplement Facts
    Serving Size: 1 SoftgelServings per Container: 60
    Amount Per Serving
    *
    AbsoFol™, under exclusive license, is trademark of Taleos Pharma Corp. (patents pending)
    Folic Acid (as Folic Acid - AbsoFol™)*1mg
    Vitamin B6 (as Pyridoxine HCl)12.5mg
    Vitamin B12 (as Cyanocobalamin)0.5mg
    Omega-3 Acids500mg
      Doconexent (DHA)350mg
      Icosapent (EPA)35mg
    Beta-sitosterol200mg
  • STORAGE

    Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

    Dispense in a well-closed, tight, light-resistant container as defined by the USP using a child resistant closure.

  • HOW SUPPLIED

    TALIVA softgels are supplied as red, opaque, oblong, coated softgels. TALIVA softgels are available in bottles of 60 (NDC: 70877-8588-01).

  • HEALTH CLAIM

    Distributed By:
    Taleos Pharma Corp.
    Eatontown, NJ 07724
    www.taleos-pharma.com

    TALIVA, ABSOFOL and TALEOS are trademarks of Taleos Pharma Corp.

  • PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

    70877-8588-1

    TALIVA

    PRESCRIPTION
    MULTI-VITAMINS

    WITH DHA/EPA

    WITH 100%
    AbsoFol

    Rx Only

    DIETARY SUPPLEMENT
    60 Softgels

    Principal Display Panel - 60 Softgel Bottle Label
  • INGREDIENTS AND APPEARANCE
    TALIVA 
    folic acid, pyridoxine hydrochloride, cyanocobalamin, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-8588
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride12.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin0.5 mg
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent350 mg
    Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent35 mg
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids35 mg
    .Beta.-Sitosterol (UNII: S347WMO6M4) (.Beta.-Sitosterol - UNII:S347WMO6M4) .Beta.-Sitosterol200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    White Wax (UNII: 7G1J5DA97F)  
    Water (UNII: 059QF0KO0R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70877-8588-160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT11/01/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)25 mm
    Labeler - Taleos Pharma (080318529)