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

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Drug Label Information

Updated June 4, 2015

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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 C55 mg92%92%
      (as ascorbic acid)
    Vitamin D31000 IU250%250%
      (as cholecalciferol)
    Vitamin E15 IU50%50%
      (as d-alpha-tocopheryl acetate)
    Thiamin1.3 mg87%76%
      (as thiamine HCl, Vitamin B1)
    Riboflavin (Vitamin B2)1.8 mg106%90%
    Niacin (as nicotinic acid)5 mg25%25%
    Vitamin B635 mg1750%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 mg250%125%
    Vitamin B1214 mcg233%175%
      (as cyanocobalamin)
    Iron (as carbonyl iron)31 mg172%172%
    Iodine200 mcg133%133%
      (as Potassium Iodide)
    Magnesium30 mg8%7%
      (as Magnesium Oxide)
    Docosahexaenoic Acid200mg**
      (DHA)
    Eicosapentaenoate Acid15 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.

  • 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.
  • CONTRAINDICATIONS

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

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

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

    Rx
    MADE IN CANADA

    Rev. 05/2015

  • 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
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15370-250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID55 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [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 HYDROCHLORIDE1.3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.8 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE35 mg
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID600 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID400 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN14 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION31 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION200 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE30 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWNScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code TriStart
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15370-250-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2015
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)