TRIPHROCAPS (FOLIC ACID, ASCORBIC ACID, NIACINAMIDE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, AND BIOTIN) CAPSULE [TRIGEN LABORATORIES

TRIPHROCAPS (FOLIC ACID, ASCORBIC ACID, NIACINAMIDE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, AND BIOTIN) CAPSULE [TRIGEN LABORATORIES
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NDC 13811-525-01
Set ID 189aa6c1-e279-4ee5-968f-da869c1cda5a
Category DIETARY SUPPLEMENT
Packager Trigen Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number
  • SUPPLEMENT FACTS

    TriphroCaps Supplement Facts Panel Rev. 06/2019

    Other Ingredients: Soybean Oil, Bovine Gelatin, Glycerin, Water, Yellow Beeswax, Lecithin, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Yellow #5, FD&C Yellow #6, and Iron Oxide Red 

    THIS PRODUCT CONTAINS SOY. 

     TriphroCaps are an orally administered prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

  • CONTRAINDICATIONS

    TriphroCaps are contraindicated in patients with a known hypersensitivity to any of the ingredients including soy.

  • PRECAUTIONS

    Folic acid alone is an 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.

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

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

    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. 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.

  • DRUG INTERACTIONS

    TriphroCaps 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

    TriphroCaps are red, oval softgel capsules, imprinted with "T9".

  • DIRECTIONS FOR USE

    Take one softgel capsule daily or as prescribed by a physician. On dialysis days, take one TriphroCaps softgel after dialysis.

  • HOW SUPPLIED

    TriphroCaps are supplied in bottles of 100 softgel capsules.

    Product Code: 13811-525-01

  • STORAGE

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

  • 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.

                                                                                                                                                                                                                                         Rev. 06/2019

    Customer Service: 1-877-482-3788

    Manufactured for:

    Trigen Laboratories, LLC

    Bridgewater, NJ 08807

     Trigen Logo

  • PRINCIPAL DISPLAY PANEL - 100 Softgel Bottle Label

    13811-525-01

    TriphroCaps
    Softgels

    100 SOFTGELS

    TRIGEN
    LABORATORIES

    TriphroCaps Bottle Label Rev. 06/2019
  • INGREDIENTS AND APPEARANCE
    TRIPHROCAPS 
    folic acid, ascorbic acid, niacinamide, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, and biotin capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid1 mg
    ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid100 mg
    niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide20 mg
    thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) Thiamine1.5 mg
    riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin1.7 mg
    pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride10 mg
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin6 ug
    calcium pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID5 mg
    biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04) biotin150 ug
    Inactive Ingredients
    Ingredient NameStrength
    soybean oil (UNII: 241ATL177A)  
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    yellow wax (UNII: 2ZA36H0S2V)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    FD&C yellow No. 5 (UNII: I753WB2F1M)  
    FD&C yellow No. 6 (UNII: H77VEI93A8)  
    ferric oxide red (UNII: 1K09F3G675)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-525-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/27/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)13 mm
    Labeler - Trigen Laboratories, LLC (830479668)