TriStart FREE by Carwin Pharmaceutical Associates, LLC TriStart™ Free

TriStart FREE by

Drug Labeling and Warnings

TriStart FREE by is a Other medication manufactured, distributed, or labeled by Carwin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRISTART FREE- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, riboflavin, niacin, folic acid, iron, magnesium oxide, and schizochytrium dha capsule, liquid filled 
Carwin Pharmaceutical Associates, LLC

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TriStart™ Free

Supplement Facts
Serving Size: 1 SoftgelServings per container: 30
Amount Per Serving:% Daily Value
In Pregnancy
  • * Percent Daily Value not established.
  • Vitamin C (Ascorbic Acid)60 mg50%
    Vitamin D3 (Cholecalciferol)25 mcg (1000 IU)167%
    Vitamin E (D–Alpha–Tocopherol)9 mcg (14 IU)48%
    Vitamin B6 (Pyridoxine HCl)50 mg2500%
    Riboflavin (Vitamin B2)1.5 mg94%
    Vitamin B3 (Niacin)12 mg75%
    Folate ( as 800 mcg Quatrefolic® ((6S–5–methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 432 mcg of Folic Acid), and 568 mcg of folic acid))1667 mcg DFE
    (1000 mcg folic acid)
    278%
    Iron (Carbonyl Iron)33 mg122%
    Magnesium (Magnesium Oxide)5 mg1%
    Algal Oil (Algal Oil, life's DHA® S40–0400 DHA 400mg/g)218 mg*

    Other Ingredients: Candelilla wax, Sunflower Lecithin, Modified Food Starch, Carrageenan, Glycerin, Sorbitol, Purified Water, and Annatto.

    INDICATIONS AND USAGE

    TriStart™ FREE is a dietary supplement indicated to provide vitamin, mineral and DHA supplementation throughout pregnancy and in the postnatal period.

    CONTRAINDICATIONS

    TriStart™ FREE should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

    PRECAUTIONS

    General

    TriStart™ FREE is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized pyridoxine.

    Folic Acid

    Administration of Folic Acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which 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.

    ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those contained herein. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

    Contact your doctor for medical advice about side effects. You may report side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1–844–700–5011.

    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.

    DOSAGE AND ADMINISTRATION

    Take one (1) softgel daily, or as directed by a healthcare practitioner.

    HOW SUPPLIED

    TriStart™ FREE is available as an oval, annatto softgel capsule with an etched imprint "FREE". Supplied in a carton unit dose pack of 30 (3 child-resistant blister cards of 10 softgels each) 15370–270–30.

    Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature]. Protect from light, moisture and heat.

    Made with Vitashine™ - a plant-derived Vegan D3 made from Lichen Extract.

    life's DHA® is a vegetarian source of Docosahexaenoic Acid (DHA).

    Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972–37–1

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

    TAMPER EVIDENT: Do not use if seal is broken or missing.

    Dispensed by a Prescription

    Manufactured for:
    Carwin Pharmaceutical Associates, LLC
    Hazlet, NJ 07730

    www.carwinpharma.com

    (Rev. 12/2020)

    PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Carton

    15370-270-30

    TriStart™ Free

    PRENATAL SUPPLEMENT

    One small softgel with DHA, Quatrefolic®,
    Iron, Vitamin D and B Vitamins to support
    your baby's growth and development.

    Dye, Sugar,
    Lactose, and
    Gluten FREE

    30 Softgels

    Dispensed by a Prescription

    PRINCIPAL DISPLAY PANEL - 30 Softgel Blister Pack Carton
    TRISTART FREE 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, riboflavin, niacin, folic acid, iron, magnesium oxide, and schizochytrium dha capsule, liquid filled
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-14 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.5 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN12 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    Iron (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) Iron33 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE5 mg
    SCHIZOCHYTRIUM DHA OIL (UNII: 2GQR19D8A4) (SCHIZOCHYTRIUM DHA OIL - UNII:2GQR19D8A4) SCHIZOCHYTRIUM DHA OIL218 ug
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:15370-270-303 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/17/202105/03/2023
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)12 mm
    imprint
    Labeler - Carwin Pharmaceutical Associates, LLC (079217215)

    Revised: 5/2023