Label: TRIGELS-F FORTE- folic acid, ascorbic acid, cyanocobalamin, and ferrous fumarate capsule

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

Drug Label Information

Updated November 24, 2021

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

  • DESCRIPTION

    Supplement Facts Panel

    Other Ingredients: Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Soy Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1


    THIS PRODUCT CONTAINS SOY.

     
    Trigels-F Forte is a prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

    Inactive Ingredients

    Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1.

  • CONTRAINDICATIONS

    Trigels-F Forte should not be used by patients with a known hypersensitivity to any of the listed ingredients including soy.  All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

  • WARNINGS

    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

    Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Trigels-F Forte. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

    Folic Acid: 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 neurologic 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 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.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates.  Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

  • OVERDOSAGE

    The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

  • DESCRIPTION

    Trigels-F Forte is a brown, oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.

  • DIRECTIONS FOR USE

    Take one softgel capsule by mouth daily or as directed by a physician.

  • HOW SUPPLIED

    Trigels-F Forte is available in child resistant blister packs of 100 (10 x 10) softgel capsules.


    Product Code: 13811-518-10

  • 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.

  • HEALTH CLAIM

    KEEP THIS PRODUCT 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 1-770-509-4500 or FDA at
    1-800-FDA-1088 or www.fda.gov/medwatch.


    PLR-TRIGELSF-00001-1                                                                Rev. 11/2021

    Manufactured for:
    Trigen Laboratories, LLC
    Alpharetta, GA 30005
    www.trigenlab.com

    Trigen Logo

  • PRINCIPAL DISPLAY PANEL - 100 Softgel Blister Pack Carton

    13811-518-10

    Trigels-F
    Forte

    Softgels

    100 SOFTGELS

    TRIGEN
    LABORATORIES

    Trigels F Forte Carton Rev. 11/2021
  • INGREDIENTS AND APPEARANCE
    TRIGELS-F FORTE 
    folic acid, ascorbic acid, cyanocobalamin, and ferrous fumarate capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-518
    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 Acid60 mg
    Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin10 ug
    Ferrous Fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION151 mg
    Inactive Ingredients
    Ingredient NameStrength
    soybean oil (UNII: 241ATL177A)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    yellow wax (UNII: 2ZA36H0S2V)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-518-1010 in 1 CARTON
    1100 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/01/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)20 mm
    Labeler - Trigen Laboratories, LLC (830479668)