Label: VITRANOL- folic acid tablet
VITREXATE- folic acid tablet

  • NDC Code(s): 59088-167-54, 59088-171-54
  • Packager: PureTek Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 24, 2021

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

  • 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
    Magnesium (as magnesium oxide)……………………… 200 mg
    Zinc (as zinc oxide)……………………………………….. 25 mg
    Selenium (as selenium 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:

    To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

  • CONTRAINDICATIONS:

    Contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • WARNING:

    Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

  • PRECAUTIONS:

    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:

    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:

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

  • DOSAGE AND ADMINISTRATION:

    One (1) caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

  • HOW SUPPLIED:

    Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets –

    NDC 59088-167-54

    NDC 59088-171-54

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

    Store at controlled room temperature 20º-25ºC (68º-77ºF). [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 20º-25ºC (68º-77ºF). [See USP].
    Protect from light and moisture and avoid excessive heat.
    To report a serious adverse event or to obtain product information, contact
    1-877-921-7873.

  • Vitrexate TM

    Manufactured in the USA by:

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

    Label

  • Vitranol TM

    Vitranol

  • INGREDIENTS AND APPEARANCE
    VITRANOL 
    folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM55 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE200 mg
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM45 ug
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE35 ug
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)2.3 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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:59088-171-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/11/2021
    VITREXATE 
    folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-167
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE200 mg
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE35 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM45 ug
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM55 ug
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    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
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    COCOA (UNII: D9108TZ9KG)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorbrown (Beige speckled caplet) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-167-5430 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)