Label: TRISTART DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent, and icosapent capsule, liquid filled

  • NDC Code(s): 15370-250-30
  • Packager: CarWin Pharmaceutical Associates, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 4, 2015

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

  • BOXED WARNING(What is this?)

    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.

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  • DESCRIPTION

    Supplement Facts
    Serving Size: 1 Softgel
    Servings per container: 30
    Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women
    *
    Daily Values (DV) not established.
    Vitamin C 55 mg 92% 92%
      (as ascorbic acid)
    Vitamin D3 1000 IU 250% 250%
      (as cholecalciferol)
    Vitamin E 15 IU 50% 50%
      (as d-alpha-tocopheryl acetate)
    Thiamin 1.3 mg 87% 76%
      (as thiamine HCl, Vitamin B1)
    Riboflavin (Vitamin B2) 1.8 mg 106% 90%
    Niacin (as nicotinic acid) 5 mg 25% 25%
    Vitamin B6 35 mg 1750% 1400%
      (as pyridoxine HCl)
    Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid) 1 mg 250% 125%
    Vitamin B12 14 mcg 233% 175%
      (as cyanocobalamin)
    Iron (as carbonyl iron) 31 mg 172% 172%
    Iodine 200 mcg 133% 133%
      (as Potassium Iodide)
    Magnesium 30 mg 8% 7%
      (as Magnesium Oxide)
    Docosahexaenoic Acid 200mg * *
      (DHA)
    Eicosapentaenoate Acid 15 mg * *
      (EPA)

    OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin.

    Contains: Soy and Fish

    TriStart DHA™ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA™ contains bovine gelatin.

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  • INDICATIONS

    TriStart DHA™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA™ can also be beneficial in improving the nutritional status of women prior to conception.1


    1
    This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.
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  • CONTRAINDICATIONS

    TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • WARNINGS

    Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.

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  • PRECAUTIONS

    Folic acid alone is 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 neurological manifestations progress.

    Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA and EPA) 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.

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  • ADVERSE REACTIONS

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

    You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122

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  • DIRECTIONS

    Adults

    Take one softgel daily with or without food, or as prescribed by a healthcare practitioner.

    Children under 12

    Consult a doctor.

    Do not exceed the recommended dose.

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  • HOW SUPPLIED

    TriStart DHA™ is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 3ct professional sample (15370-250-03).

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

    TriStart DHA™ should be administered only under the direct supervision of a healthcare practitioner.

    Avoid excessive heat, light and moisture.

    Keep out of reach of children.

    Tamper Evident

    Do not use if seal is broken or missing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    CarWin Pharmaceutical Associates, LLC
    Slidell, LA 70461

    Rx
    MADE IN CANADA

    Rev. 05/2015

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  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    15370-250-30

    TriStart
    DHA

    PRENATAL SUPPLEMENT

    Dye Free, Lactose, Gluten
    and Sugar Free

    Rx
    30 Softgels

    Principal Display Panel - 30 Capsule Bottle Label
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  • INGREDIENTS AND APPEARANCE
    TRISTART DHA 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent, and icosapent capsule, liquid filled
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-250
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 55 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 1000 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 1.3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.8 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 35 mg
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 600 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 14 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 31 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 200 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 200 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARAMEL (UNII: T9D99G2B1R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ORANGE (UNII: 5EVU04N5QU)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Product Characteristics
    Color BROWN Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code TriStart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15370-250-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 06/01/2015
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
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