TRIPHROCAPS (FOLIC ACID, ASCORBIC ACID, NIACINAMIDE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, AND BIOTIN) CAPSULE [STATE OF FLORIDA DO

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  • TRIPHROCAPS (FOLIC ACID, ASCORBIC ACID, NIACINAMIDE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, AND BIOTIN) CAPSULE [STATE OF FLORIDA DO

TRIPHROCAPS (FOLIC ACID, ASCORBIC ACID, NIACINAMIDE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, AND BIOTIN) CAPSULE [STATE OF FLORIDA DO
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NDC 53808-0987-1
Set ID c82844d9-6986-431c-9c5f-95a8b4f7c11d
Category DIETARY SUPPLEMENT
Packager State of Florida DOH Central Pharmacy
Generic Name
Product Class
Product Number
Application Number
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  • HEALTH CLAIM

    Rx Only

  • DESCRIPTION

    TriphroCaps are an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. TriphroCaps are red, oval softgel capsules, imprinted "T9."

    Supplement Facts
    Servings per Bottle: 100
    Serving Size: 1 Softgel Capsule
    Each Softgel Capsule contains    		%DV Adults & Children
    4 Years or More
    Folate1 mg250%
    Vitamin C (ascorbic acid)100 mg167%
    Niacin (niacinamide)20 mg100%
    Thiamine (thiamine mononitrate)1.5 mg100%
    Riboflavin1.7 mg100%
    Vitamin B6 (pyridoxine HCl)10 mg500%
    Vitamin B12 (cyanocobalamin)6 mcg100%
    Pantothenic Acid (calcium pantothenate)5 mg50%
    Biotin150 mcg50%

    Inactive Ingredients: Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Bees Wax, Lecithin, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide.

  • INDICATIONS AND USAGE

    TriphroCaps are indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

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

  • CONTRAINDICATIONS

    TriphroCaps is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • WARNINGS

    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.

    THIS PRODUCT CONTAINS SOY.

  • PRECAUTIONS

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function of concomitant disease or other drug therapy.

  • ADVERSE REACTIONS

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

  • DOSAGE AND ADMINISTRATION

    Take one TriphroCaps softgel 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.

    They are supplied by State of Florida DOH Central Pharmacy as follows:

    NDCQuantity/FormColorSource Prod. Code
    53808-0987-130 Capsules in a Blister PackRED13811-525
  • 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

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

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN

  • HEALTH CLAIM

    Rx Only

    All prescriptions using this product shall be pursuant to state 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

    This Product was Repackaged By:

    State of Florida DOH Central Pharmacy
    104-2 Hamilton Park Drive
    Tallahassee, FL 32304
    United States

  • PACKAGE LABEL

    Label Image for 53808-0987

    Label Image for 1mg / 100mg / 20mg / 1.5mg / 1.7mg / 10mg / 6ug / 5mg / 150ug

  • 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:53808-0987(NDC: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) PANTOTHENIC ACID5 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    GELATIN (UNII: 2G86QN327L)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:53808-0987-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/01/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    scoring1
    imprint
    size (solid drugs)13 mm
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0987)
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