Label: MULTITOL-M- multivitamin, folate tablet

  • 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 April 17, 2024

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

  • DESCRIPTION:

    Each caplet contains:

    Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE
    Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg
    Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU)
    Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg
    Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg
    Riboflavin …………………………….….…..………….... 3.4 mg
    Niacin (as Niacinamide)…………………………………… 20 mg
    Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg
    Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE
    (1200 mcg as L-5-Methylfolate)
    Vitamin B12 (as Methylcobalamin)………………………….. 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. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8).

  • INDICATIONS:

    Multitol-M™ is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

  • CONTRAINDICATIONS:

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

  • WARNING:

    Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

  • PRECAUTIONS:

    Folate 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 folate to patients with undiagnosed anemia, since folate 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 B 12 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:

    Multitol-M™ 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:

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

  • DOSAGE AND ADMINISTRATION:

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

  • HOW SUPPLIED:

    Multitol-M™ are beige speckled, oblong, coated caplets in bottle containing 30 caplets (NDC 59088-005-54).
    Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

  • 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].

  • Multitol-M TM

    Manufactured in the USA by:
    PureTek Corporation

    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    MULTITOL-M 
    multivitamin, folate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-005
    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-13.5 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
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM2040 ug
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN8 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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCOA (UNII: D9108TZ9KG)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Coloryellow (Beige speckled caplet) Scoreno score
    ShapeCAPSULE (Oblong Caplet) Size19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-005-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2024
    Labeler - PureTek Corporation (785961046)