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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

  • DESCRIPTION

    Taronâ„¢-Prex Prenatal with DHA capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with "T543"

    • 1.25 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid from purified fish oil)
    • Essential vitamins and minerals

    Supplement Facts

     Servings per Bottle: 30

    *From approximately 350 mg of Omegas derived from approximately 380 mg purified fish oil.†Daily value not established.
    Serving Size: 1 Softgel Capsule
    Each Softgel Capsule contains:
    %DV for Pregnant and
    Lactating Women
    Vitamin C(ascorbic acid, USP) 25 mg 42%
    Calcium (tribasic calcium phosphate, NF) 160 mg 12%
    Iron (ferrous fumarate, USP) 30 mg 167%
    Vitamin D3 (cholecalciferol, USP) 170 IU 43%
    Vitamin E (d-alpha tocopherol, USP) 30 IU 100%
    Vitamin B6 (pyridoxine HCl, USP) 25 mg 1000%
    Folic Acid, USP 1.2 mg 150%
    DHA (docosahexaenoic acid) 265 mg* †
    Docusate Sodium, USP not more than 55 mg 4%

    Inactive Ingredients: Gelatin, Glycerin, Soy Lecithin, Water, Lecithin, Yellow Beeswax, Natural Orange Cream Flavor O.S, Sorbitol, Soybean Oil, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, and FD&C Blue #1.


  • INDICATIONS AND USAGE

    Taronâ„¢-Prex Prenatal with DHA capsules are indicated to provide vitamin/mineral and 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 fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.


  • WARNINGS

    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 International Normalized Ratio (INR). 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.


  • SAFE HANDLING WARNING

    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.

    THIS PRODUCT CONTAINS SOY AND FISH OIL.


  • 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.


  • ADVERSE REACTIONS

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


  • CAUTION

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.


  • RECOMMENDED USE

    Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician.


  • HOW SUPPLIED

    Taronâ„¢-Prex Prenatal with DHA capsules are available 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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

    All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Rx Only

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Manufactured For:
    TRIGEN Laboratories, Inc.
    Sayreville, NJ 08872
    www.trigenlab.com

    Rev. 07/13


  • PRINCIPAL DISPLAY PANEL

    13811-543-30

    Rx Only

    Taronâ„¢-Prex Prenatal
    with DHA CAP

    RX PRENATAL VITAMIN

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

    30 CAPSULES

    TRIGEN
    LABORATORIES

    Taron Prex

    Taron Prex



  • 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)