TARON-PREX PRENATAL (ASCORBIC ACID, TRIBASIC CALCIUM PHOSPHATE, FERROUS FUMARATE, CHOLECALCIFEROL, D-ALPHA TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCOSAHEXAENOIC ACID, AND DOCUSATE

TARON-PREX PRENATAL (ASCORBIC ACID, TRIBASIC CALCIUM PHOSPHATE, FERROUS FUMARATE, CHOLECALCIFEROL, D-ALPHA TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCOSAHEXAENOIC ACID, AND DOCUSATE
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NDC 13811-543-30
Set ID f298af01-aae7-45d8-b2ea-db9139d858fc
Category DIETARY SUPPLEMENT
Packager Trigen Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number
  • SUPPLEMENT FACTS

    Taron-Prex Prenatal with DHA Supplement Facts Panel Rev. 06/2019

    Other Ingredients: Gelatin (Bovine), Glycerin, Soy Lecithin, Purified Water, Yellow Beeswax, Natural and Artificial Orange Cream Flavor, Sorbitol, Soybean Oil, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, and FD&C Blue #1

     THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

    Taron™-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. Taron™ Prex Prenatal with DHA may be useful in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

    Taron™-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

    Taron™-Prex Prenatal with DHA capsules is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. 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

    Taron™-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 1-877-482-3788 or FDA at 1-800-FDA-1088.


                                                                                                                                                                                              Rev. 09/2019

     Customer Service: 1-877-482-3788                                                                                                                           Rev072018


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

  • PRINCIPAL DISPLAY PANEL

    13811-543-30

    Taron™-Prex Prenatal
    with DHA CAP

    30 CAPSULES

    TRIGEN
    LABORATORIES

    Taron Prex Prenatal Bottle labelTaron Prex Prenatal Bottle label

  • 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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-543
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID25 mg
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION160 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL170 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.2 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT265 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-543-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/01/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)20 mm
    Labeler - Trigen Laboratories, LLC (830479668)