TL-Select Softgel Capsules

TL-Select by

Drug Labeling and Warnings

TL-Select by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TL-SELECT- ascorbic acid, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, doconexent, and docusate sodium capsule 
Trigen Laboratories, LLC

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TL-Select
Softgel Capsules

Rx Only

DESCRIPTION

TL-Select is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is oblong, brown and imprinted with "TL600".

  • 1.25 mg Folic Acid and 325 mg DHA
    (key omega-3 fatty acid from purified fish oil.)
  • Essential vitamins and minerals.
  • * Derived from at least 281.7 mg Omega-3s from at least 396.8 mg purified fish oil.
    THIS PRODUCT CONTAINS SOY AND FISH OIL.
  • Daily value not established.
  • Supplement Facts
    Servings per Bottle: 30
    Serving Size: 1 Softgel Capsule%DV for Pregnant and
    Each Softgel Capsule containsLactating Women
    Vitamin C (ascorbic acid)28 mg47%
    Vitamin E (d-alpha tocopherol)30 IU100%
    Vitamin B6 (pyridoxine HCl)25 mg1000%
    Folic Acid, USP1.25 mg156%
    Calcium (tribasic calcium phosphate)160 mg12%
    Iron (ferrous fumarate)29 mg161%
    Vitamin D3 (cholecalciferol)800 IU200%
    DHA (docosahexaenoic acid, from oil derived from fish)325 mg*
    Docusate Sodium, USP55 mg4%

    Inactive Ingredients: Gelatin, Glycerin, Purified Water, Soybean Oil, Lecithin, Yellow Beeswax, Natural Creamy Orange Flavor, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Yellow #5, and FD&C Blue #1.

    INDICATIONS

    TL-Select is indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. TL-Select may be useful in improving the nutritional status of women prior to conception.

    CONTRAINDICATIONS

    TL-Select is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

    WARNING

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

    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.

    THIS PRODUCT CONTAINS SOY AND FISH OIL.

    PRECAUTION

    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 remain progressive.

    ADVERSE REACTIONS

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

    CAUTION

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

    HOW SUPPLIED

    TL-Select is available in bottles of 30 softgel capsules.

    Product Code: 13811-600-30

    STORAGE

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

    KEEP OUT OF THE REACH OF CHILDREN.

    Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

    All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Rx Only

    Manufactured for:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com

    TRIGEN
    LABORATORIES

    Rev. 11/12

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    13811-600-30
    Rx Only

    TL-Select
    Softgel Capsule

    • 1.25 mg Folic Acid and 325 mg DHA
      (key omega-3 fatty acid)
    • Essential vitamins and minerals

    30 CAPSULES

    TRIGEN
    LABORATORIES

    Principal Display Panel - 30 Capsule Bottle Label
    TL-SELECT 
    ascorbic acid, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, doconexent, and docusate sodium capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid28 mg
    .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 Acid1.25 mg
    Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation160 mg
    Ferrous Fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation29 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol800 [iU]
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent325 mg
    Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium55 mg
    Inactive Ingredients
    Ingredient NameStrength
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Soybean Oil (UNII: 241ATL177A)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ethyl Vanillin (UNII: YC9ST449YJ)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-600-3090 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/01/201103/31/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)27 mm
    Labeler - Trigen Laboratories, LLC (830479668)

    Revised: 11/2019