Label: VITREXATE FE- ferrous fumarate, folic acid tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 17, 2021

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  • DESCRIPTION:

    Each caplet contains:

    Vitamin A (as retinyl acetate)………………………….. 1500 mcg

    Vitamin C (as ascorbic acid)……………………………… 120 mg

    Vitamin D3 (as cholecalciferol)…………………………… 20 mcg

    Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg

    Thiamine (as thiamine mononitrate)………………………… 3 mg

    Riboflavin (vitamin B2)……………………………………. 3.4 mg

    Niacin (as niacinamide)…………………………………… 20 mg

    Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg

    Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

    Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg

    Calcium (as calcium carbonate)…………………………. 200 mg

    Iron (as ferrous fumarate)………………………………… 27 mg

    Magnesium (as magnesium oxide)……………………… 200 mg

    Zinc (as zinc oxide)……………………………………….. 25 mg

    Selenium (as selinium amino acid chelate)………………. 55 mcg

    Manganese (as manganese sulfate)……………………… 2.3 mg

    Chromium (as chromium polynicotinate)……………….. 35 mcg

    Molybdenum (as molybdenum amino acid chelate)……… 45 mcg

    Other Ingredients:
    organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).

  • INDICATIONS:

    Vitrexate FE is indicated for the treatment of iron deficiency anemia

    and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive

    blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and

    vitamin C deficiency occur together, along with a deficient intake or increased need for

    B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in

    convalescence.

  • CONTRAINDICATIONS:

    This product 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.

  • 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.

    Administration of folic acid alone is improper therapy for pernicious anemia and other

    megaloblastic anemias in which vitamin B12 is deficient.

    Precaustion Section

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic

    remission can occur while neurological manifestations remain progressive.

    There is a potential danger in administering folic acid to patients with undiagnosed anemia,

    since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic

    manifestations of the disease while allowing the neurologic complications to progress. This may

    result in severe nervous system damage before the correct diagnosis is made. Adequate doses

    of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious

    anemia.

    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements

    should be considered.

    For use on the order of a healthcare practitioner.

    Call your doctor about side effects. To report side effects, call PureTek Corporation at

    1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Drug Interactions:

    Vitrexate FE 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 or Clopidogrel).

    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, giving Vitrexyl + Iron after meals

    may control occasional gastrointestinal disturbances. Vitrexyl + Iron is best absorbed when

    taken at bedtime.

    Adverse reactions have been reported with specific vitamins and minerals but generally at levels

    substantially higher than those contained herein. However, allergic and idiosyncratic reactions

    are possible at lower levels. Iron, even at the usual recommended levels, has been associated

    with gastrointestinal intolerance in some patients.

  • OVERDOSE:

    Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and

    vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include

    pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally

    ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe

    reactions, including fatalities, have resulted. Vitrexate FE should be stored beyond the

    reach of children to prevent accidental iron poisoning. Keep this and all other drugs

    out of 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.

  • DOSAGE AND ADMINISTRATION:

    Adults (persons over 12 years of age) One (1) VitrexylTM + Iron
    caplet daily, between meals or as directed by a physician. Do not administer to children under
    the age of 12.

  • HOW SUPPLIED:

    Vitrexate FE are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-168-54. Dispense in a tight, light-resistant

    container as defined in the USP/NF with a child-resistant closure.

    Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light

    and moisture and avoid excessive heat.

  • STORAGE:

    Do not use if bottle seal is broken.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].

    Protect from light and moisture and avoid excessive heat.

    To report a serious adverse event or to obtain product information, contact 877-921-7873.

  • Vitrexate FE

    Manufactured in the USA by:
    PureTek Corporation

    Panorama City, CA 91402
    Questions? Call toll-free:
    1-877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    VITREXATE FE 
    ferrous fumarate, folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE35 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)2.3 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE200 mg
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM45 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM55 ug
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    COCOA (UNII: D9108TZ9KG)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorbrown (BEIGE SPECKLED CAPLET) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-168-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/30/2020
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-168) , pack(59088-168) , label(59088-168) , relabel(59088-168) , repack(59088-168)