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 kit

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 29, 2019

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

  • SUPPLEMENT FACTS

    Multivitamin/Multimineral Tablet

     

     Triveen Duo DHA Supplement Facts Rev. 082019

    Other Ingredients: Tablet: Microcrystalline Cellulose, Yellow Coating (Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol,Talc, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, FD&C Blue #2 Lake) Croscarmellose Sodium, Tripotassium Citrate, Citric Acid, Acacia, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid.

    Omega-3 Fatty Acid Capsule

    Triveen Duo DHA Supplement Facts for the Omega-3 Fatty Acid Capsule Rev. 082019

    Other Ingredients: Vegetarian Softgel: Modified Food Starch, Carrageenan, Sorbitol, Glycerin, and Purified Water.


    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.

  • CONTRAINDICATIONS

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

  • 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.
  • 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.

  • 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).

  • ADVERSE REACTIONS

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

  • DESCRIPTION

    Triveen™-Duo DHA tablet is a yellow, oval tablet imprinted with “T591” on one side. Triveen™-Duo DHA softgel capsule is a clear, oval softgel containing yellow oil.

  • DIRECTIONS 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.

  • 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

  • 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.

  • 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 1-877-482-3788 or FDA at 1-800-FDA-1088.


    Customer Service: 1-877-482-3788                                                                                                                                Rev. 08/2019

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    13811-591-30

    Triveen-Duo DHA

    30 Day Supply
    30 tablets and 30 softgel capsules

    TRIGEN
    LABORATORIES

    Triveen Duo DHA Carton Rev. 08/2019
  • 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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-591
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-591-305 in 1 CARTON
    11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE3000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) THIAMINE1.8 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION25 mg
    IRON PROTEIN SUCCINYLATE (UNII: VBJ9L90P4L) (IRON PROTEIN SUCCINYLATE - UNII:VBJ9L90P4L) IRON PROTEIN SUCCINYLATE4 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT11/01/2010
    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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT275 mg
    Inactive Ingredients
    Ingredient NameStrength
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT11/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT11/01/2010
    Labeler - Trigen Laboratories, LLC (830479668)