TL-Care DHA by Trigen Laboratories, Inc. TL-Care DHA Softgels

TL-Care DHA by

Drug Labeling and Warnings

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

Drug Details [pdf]

TL-CARE DHA- fish, doconexent, icosapent, thiamine mononitrate, riboflavin, inositol niacinate, pyridoxine hydrochloride, cyanocobalamin, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, biotin, ferrous fumarate, zinc sulfate monohydrate, cupric sulfate anhydrous, and docusate sodium capsule 
Trigen Laboratories, LLC

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TL-Care DHA
Softgels

Rx Only

DESCRIPTION

TL-Care DHA is an orally administered prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish based DHA. Each softgel capsule is oblong, purple and imprinted with "TL517."

Supplement Facts
Servings per Bottle: 90
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains:
%DV for Pregnant and
Lactating Women
  • * Daily value not established.
  • Fish Oil Concentrate 10/50 TG500 mg *
      DHA215 mg *
      EPA45 mg *
    Vitamin B1 (thiamine nitrate)3 mg176%
    Vitamin B2 (riboflavin)3.4 mg170%
    Vitamin B3 (inositol nicotinate)20 mg100%
    Vitamin B6 (pyridoxine HCl, USP)25 mg1000%
    Vitamin B12 (cyanocobalamin)100 mcg1250%
    Folic Acid1 mg125%
    Vitamin C (ascorbic acid)60 mg100%
    Vitamin D3 (cholecalciferol)800 IU200%
    Vitamin E (d-alpha tocopherol)30 IU100%
    Biotin300 mcg100%
    Iron (ferrous fumarate)27 mg150%
    Zinc (zinc sulfate monohydrate)10 mg67%
    Copper (cupric sulfate anhydrous)2 mg100%
    Docusate Sodium25 mg1.7%

    Inactive Ingredients: Gelatin, Glycerin, Purified Water, Sorbitol Special, Titanium Dioxide, Lemon Flavor, Carmine, and FD&C Blue #1.

    INDICATIONS

    TL-Care DHA softgel capsules are 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-Care DHA may be useful in improving the nutritional status of women prior to conception.

    CONTRAINDICATIONS

    TL-Care DHA 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.

    THIS PRODUCT CONTAINS FISH OIL AND SOY.

    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.

    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.

    HOW SUPPLIED

    TL-Care DHA is supplied in child-resistant bottles of 30 or 90 softgel capsules each.

    Product Code: 13811-517-30
    Product Code: 13811-517-90

    STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Contact with moisture may produce surface discoloration or erosion of the softgel.

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

    KEEP OUT OF THE REACH OF CHILDREN.

    Rx Only

    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.

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

    Rev. 03/13

    PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

    13811-517-90
    Rx Only

    TL-Care DHA

    Softgel Capsule

    90 SOFTGELS

    TRIGEN
    LABORATORIES

    Principal Display Panel - 90 Capsule Bottle Label
    TL-CARE DHA 
    fish, doconexent, icosapent, thiamine mononitrate, riboflavin, inositol niacinate, pyridoxine hydrochloride, cyanocobalamin, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, biotin, ferrous fumarate, zinc sulfate monohydrate, cupric sulfate anhydrous, and docusate sodium capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-517
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL500 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT215 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT45 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    INOSITOL NIACINATE (UNII: A99MK953KZ) (INOSITOL NIACINATE - UNII:A99MK953KZ) INOSITOL NIACINATE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN100 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    diethylcarbamazine (UNII: V867Q8X3ZD)  
    FD&C blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-517-3030 in 1 BOTTLE
    2NHRIC:13811-517-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/29/201301/31/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)26 mm
    Labeler - Trigen Laboratories, LLC (830479668)

    Revised: 11/2019