Label: TRIVEEN-DUO DHA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryol acetate-dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous bisglycinate, iron protein succinylate, magnesium oxide, zinc oxide, cupric oxide, and doconexent

  • NDC Code(s): 13811-591-30
  • Packager: Trigen Laboratories, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 31, 2018

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

  • SUPPLEMENT FACTS

    TabletCapsule

    THIS PRODUCT CONTAINS FISH OIL (ANCHOVY).

    Triveen™-Duo DHA is a prescription prenatal multivitamin/ multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish oil.

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  • WARNINGS

    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.
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  • PRECAUTIONS

    General: 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.


    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.


    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.


    Pediatric Use: Safety and effectiveness in pediatric patients have not been established


    Geriatric Use: Safety and effectiveness in elderly populations have not been established.

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  • DRUG INTERACTIONS

    Triveen™-Duo DHA is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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  • ADVERSE REACTIONS

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

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  • DESCRIPTION

    Triveen™-Duo DHA tablet is a yellow, oval tablet imprinted with "T591".  Triveen™-Duo DHA softgel capsule is a clear, oval softgel containing pale yellow oil.

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  • DIRECTION FOR USE

    Take one tablet and one soft gelatin capsule by mouth daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day.

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  • HOW SUPPLIED

    Triveen™-Duo DHA is supplied in a 30 day child-resistant unit-of-use dispensing carton containing 5 blister cards of 6 tablets and 6 soft gelatin capsules each. 

    Product Code: 13811-591-30

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  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

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  • HEALTH CLAIM

    KEEP OUT OF REACH OF CHILDREN.


    For use on the order of a healthcare practitioner.


    Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


    Customer Service: 1-888-987-4436                                                                                                                                 Rev. 08/2018

                                                                                                                                                                                         TrigenLogo
    Manufactured for:
    Trigen Laboratories, LLC
    Bridgewater, NJ 08807
    www.trigenlab.com

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    13811-591-30

    Triveen-Duo DHA

    30 Day Supply
    30 tablets and 30 softgel capsules

    TRIGEN
    LABORATORIES

    Rev082018
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  • INGREDIENTS AND APPEARANCE
    TRIVEEN-DUO DHA 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryol acetate-dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous bisglycinate, iron protein succinylate, magnesium oxide, zinc oxide, cupric oxide, and doconexent kit
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-591
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-591-30 5 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK
    Part 2 1 BLISTER PACK
    Part 1 of 2
    TRIVEEN-DUO DHA 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryol acetate-dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous bisglycinate, iron protein succinylate, magnesium oxide, zinc oxide, cupric oxide, and doconexent tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 3000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 15 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 200 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 25 mg
    IRON PROTEIN SUCCINYLATE (UNII: VBJ9L90P4L) (IRON PROTEIN SUCCINYLATE - UNII:VBJ9L90P4L) IRON PROTEIN SUCCINYLATE 4 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ACACIA (UNII: 5C5403N26O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    TALC (UNII: 7SEV7J4R1U)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 11/01/2010
    Part 2 of 2
    TRIVEEN-DUO DHA 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryol acetate-dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous bisglycinate, iron protein succinylate, magnesium oxide, zinc oxide, cupric oxide, and doconexent capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 275 mg
    Inactive Ingredients
    Ingredient Name Strength
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 11/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 11/01/2010
    Labeler - Trigen Laboratories, LLC (830479668)
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