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

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

Drug Label Information

Updated April 6, 2018

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  • HEALTH CLAIM

    Rx Only

  • DESCRIPTION

    TALIMENT is a prescription multi-vitamin in the form of a red, oblong softgel.

  • INDICATION AND USAGE

    TALIMENT 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
    Folic Acid 1mg
    Vitamin B6 (as Pyridoxine HCl)15mg
    Vitamin B12 (as Cyanocobalamin)0.5mg
    Coenzyme Q10 (as Ubiquinone)50mg
    Omega-3 Acids800mg
      Doconexent (DHA)350mg
      Icosapent (EPA)80mg
    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

    TALIMENT softgels are supplied as red oblong, softgels. TALIMENT softgels are available in bottles of 60 (NDC: 70877-5776-6). Each tablet of TALIMENT contains 1 mg of Folic Acid , 15 mg of pyridoxine hydrochloride, 0.5 mg of cyanocobalamin, 50 mg of coenzyme Q10, 800 mg of omega-3 acids including 350 mg of Doconexent, 80 mg of Icosapent, and 200 mg of beta-sitosterol.

  • HEALTH CLAIM

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

    TALIMENT and TALEOS are trademarks of Taleos Pharma Corp.

  • PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

    70877-5776-6

    TALIMENT

    PRESCRIPTION
    MULTI-VITAMINS

    Rx Only        60 SOFTGELS

    DIETARY SUPPLEMENT

    Principal Display Panel - 60 Softgel Bottle Label
  • INGREDIENTS AND APPEARANCE
    TALIMENT 
    folic acid, pyridoxine hydrochloride, cyanocobalamin, ubiquinone, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol capsule, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-5776
    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 HYDROCHLORIDE15 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.5 mg
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE50 mg
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS800 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT350 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT80 mg
    .BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70877-5776-660 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/09/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)24 mm
    Labeler - Taleos Pharma (080318529)