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Taron-Prex (TRIGEN Laboratories, Inc.)

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CAPSULE 30 CAPSULE in 1 BOTTLE (13811-543-30) Label Information

Complete Taron-Prex Information

  • SUPPLEMENT FACTS

    REV072018

    THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

     
    Taronâ„¢-Prex Prenatal with DHA capsules is a prescription multivitamin/mineral indicated to provide fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Taronâ„¢ Prex Prenatal with DHA may be useful in improving the nutritional status of women prior to conception.


  • CONTRAINDICATIONS

    Taronâ„¢-Prex Prenatal with DHA capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients, including soy or fish products. Do not take this product if you are currently taking mineral oil, unless directed by a doctor.


  • WARNINGS

    Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

     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.


  • PRECAUTIONS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias here 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.

    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.


  • DRUG INTERACTIONS

    There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).


  • ADVERSE REACTIONS

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


  • DESCRIPTION

    Taron™-Prex Prenatal with DHA is a maroon, oblong softgel capsule imprinted with “T543”.


  • DIRECTIONS FOR USE

    Take one softgel capsule by mouth daily or as prescribed by a physician.


  • HOW SUPPLIED

    Taronâ„¢-Prex Prenatal with DHA is dispensed in bottles of 30 softgel capsules.

    Product Code: 13811-543-30


  • STORAGE

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


  • HEALTH CLAIM

    KEEP OUT OF REACH OF CHILDREN.


    For use on the order of a healthcare practitioner.


    Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


                                                                                                                                                                                              Rev. 07/2018

     Customer Service: 1-888-987-4436                                                                                                                           Rev072018


    Manufactured for:
    Trigen Laboratories, LLC
    Bridgewater, NJ 08807
    www.trigenlab.com


  • PRINCIPAL DISPLAY PANEL

    13811-543-30

    Taronâ„¢-Prex Prenatal
    with DHA CAP

    • 1.2 mg Folic Acid and 265 mg DHA
      (key omega-3 fatty acid)
    • Essential vitamins and minerals

    30 CAPSULES

    TRIGEN
    LABORATORIES

    Rev072018


  • INGREDIENTS AND APPEARANCE
    TARON-PREX  PRENATAL
    ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, d-alpha tocopherol, pyridoxine hydrochloride, folic acid, docosahexaenoic acid, and docusate sodium capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-543
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 25 mg
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 160 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 30 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 170 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 30 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.2 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 265 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 55 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SORBITOL (UNII: 506T60A25R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-543-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 12/01/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    flavor
    imprint
    scoring 1
    shape
    size (solid drugs) 20 mm
    Labeler - Trigen Laboratories, LLC (830479668)