Label: FOLIVANE-PLUS WITH ASCORBIC ACID PRECURSORS- ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hcl, folic acid, cyanocobalamin, biotin, d-calcium pantothenate, ferrous fumarate, and polysaccharide iron complex capsule

  • NDC Code(s): 13811-539-90
  • Packager: Trigen Laboratories, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated May 23, 2018

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

  • SUPPLEMENT FACTS

    Rev.072018

    Folivane™ - Plus is a prescription multivitamin nutritional supplement indicated for improving nutritional status in adults with certainty illnesses or vitamin deficiencies. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.

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  • CONTRAINDICATIONS

    Folivane™ - Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

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  • WARNINGS
  • PRECAUTIONS

    General: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.


    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including 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.

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


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

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  • DRUG INTERACTIONS

    There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g. Aspirin, Heparin, Clopidogrel).

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  • ADVERSE REACTIONS

    Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


    Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, taking Folivane™ - Plus after meals may diminish occasional G.I. disturbances. Folivane™ - Plus is best absorbed when taken at bedtime.

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  • OVERDOSAGE

    Acute overdosage of iron may cause abdominal pain, nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other more chronic symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Toxic effects are seen at 10-20 mg/kg elemental iron. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folivane™-Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product out of the reach of children.

    Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.


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  • DESCRIPTION

    Folivane™ - Plus are maroon capsules imprinted “T539” in white.

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  • DIRECTIONS FOR USE

    Adults and children over 12 years of age: One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.

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  • HOW SUPPLIED

    Folivane™ - Plus is dispensed in child-resistant bottles of 90 capsules.

    Product Code: 13811-539-90

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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].

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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 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. 07/2018


    Manufactured For:                                                                                                      trigen logo
    Trigen Laboratories, LLC
    Bridgewater, NJ 08807

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  • PRINCIPAL DISPLAY PANEL

    Folivane-Plus with Ascorbic Acid Precursors 90ct

    13811-539-90

    Folivane-PlusBLREV072018
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  • INGREDIENTS AND APPEARANCE
    FOLIVANE-PLUS WITH ASCORBIC ACID PRECURSORS 
    ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hcl, folic acid, cyanocobalamin, biotin, d-calcium pantothenate, ferrous fumarate, and polysaccharide iron complex capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-539
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 62.5 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 62.5 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 210 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 5 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 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 10 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-539-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 10/01/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    imprint
    scoring 1
    shape
    size (solid drugs) 23 mm
    Labeler - Trigen Laboratories, LLC (830479668)
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