Label: TARON-C DHA- ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, zinc sulfate, and omega-3 fatty acids capsule

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

Drug Label Information

Updated December 22, 2021

If you are a consumer or patient please visit this version.

  • SUPPLEMENT FACTS

    Taron-C DHA Supplement Facts

    Other Ingredients: Bovine Gelatin, Glycerin, Yellow Beeswax, Soy Lecithin, Purified Water, Orange Cream Flavor O.S, Sorbitol, Titanium Dioxide, Ethyl Vanillin, FD&C Blue #1.


    THIS PRODUCT CONTAINS SOY AND FISH (TUNA, MAY INCLUDE ANCHOVY AND/OR SARDINE).

     
    Taron™-C DHA is a prescription multivitamin/mineral indicated to provide omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Taron™-C DHA may be useful in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

    Taron™-C DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients including soy or fish products. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

  • 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 an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.


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


    Pediatric Use: Safety and effectiveness in pediatric populations have not been established.


    Geriatric Use: Safety and effectiveness in elderly populations have not been established.


    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

  • DRUG INTERACTIONS

    Taron™-C DHA 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

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


    Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Taron™-C DHA after meals may control occasional G.I. disturbances. Taron™-C DHA is best absorbed when taken at bedtime.

  • OVERDOSAGE

    Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Taron™-C DHA should be stored beyond the reach of children to prevent against accidental iron poisoning.


    Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

  • DESCRIPTION

    Taron™-C DHA is a blue, oval softgel capsule containing a dark brown oil, imprinted with “T536”.

  • DIRECTIONS FOR USE

    Adults (over 12 years of age) may take one capsule daily between meals or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

  • HOW SUPPLIED

    Taron™-C DHA is dispensed in child-resistant bottles of 30 softgel capsules.

    PRODUCT CODE 13811-536-30

  • 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 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

                                                                                                                                                       Rev. 12/2021
    PLR-TARONCDHA-00001-2


    Manufactured for:
    Trigen Laboratories, LLC
    Alpharetta, GA 30005
    www.trigenlab.com

    Trigen logo

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    13811-536-30

    Taron-C DHA
    with Ascorbic Acid Precursors

    PRENATAL MULTIVITAMIN SUPPLEMENT

    30 CAPSULES

    TRIGEN
    LABORATORIES

    Taron C DHA BL Rev. 12/2021
  • INGREDIENTS AND APPEARANCE
    TARON-C DHA 
    ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, zinc sulfate, and omega-3 fatty acids capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-536
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION17.5 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON17.5 mg
    ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid25 mg
    folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid1 mg
    thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE2 mg
    riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) riboflavin3 mg
    Niacin (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) Niacin1.8 mg
    calcium pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride25 mg
    biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) biotin300 ug
    cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) cyanocobalamin12.5 ug
    Cupric Sulfate (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE ANHYDROUS5 mg
    zinc sulfate (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
    Omega-3 fatty acids (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) Omega-3 fatty acids200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    yellow wax (UNII: 2ZA36H0S2V)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    FD&C blue No. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-536-3030 in 1 BOTTLE, PLASTIC
    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)15 mm
    Labeler - Trigen Laboratories, LLC (830479668)