Label: DIATROL- vitamins and mineral capsule

  • 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 1, 2024

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

  • Each Caplet Contains:


    Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE
    Vitamin C (as Ascorbic Acid)................................................. 50 mg
    Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg
    Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg
    Vitamin K1 (as Phytonadione)............................................. 90 mcg
    Thiamin (as Thiamine Mononitrate)......................................... 4 mg
    Riboflavin ................................................................................. 4 mg
    Niacin (as Niacinamide)......................................................... 24 mg
    Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg
    Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE
    (1000 mcg as L-5-Methylfolate)
    Vitamin B12 (as Methylcobalamin)........................................ 8 mcg
    Biotin (as D-biotin)............................................................... 30 mcg
    Pantothenic Acid ...................................................................... 8 mg
    Chromium (as Chromium Nicotinate)............................... 200 mcg
    Gymnema Sylvestre Leaf Powder........................................ 100 mg
    L-Arginine HCl...................................................................... 60 mcg
    Vanadyl Sulfate....................................................................... 15 mg

  • Other Ingredients:

    Croscarmellose Sodium, Dicalcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate (Vegetable Source), Microcrystalline Cellulose, PEG-8, Silicon Dioxide, Stearic Acid (Vegetable), Stevia Rebaudiana Leaf Extract, Flavor.

  • INDICATIONS AND USAGE

    Diatrol™ is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.

    Contraindications:

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

  • WARNING

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • PRECAUTIONS

    Folate 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 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 licensed 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.

  • Adverse Reactions:

    Folate: Allergic sensitizations 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

    Take one (1) caplet daily or as directed by a licensed healthcare practitioner.

  • HOW SUPPLIED

    Diatrol™ caplets are light green with brown speckles and dispensed in a child-resistant bottle containing 30 caplets (NDC 59088-162-54). All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

  • STORAGE

    Do not use if bottle seal is broken.
    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Protect from light and moisture and avoid excessive heat.

  • Diatrol™

    Manufactured in the USA by:
    PureTek Corporation

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

    Label

  • INGREDIENTS AND APPEARANCE
    DIATROL 
    vitamins and mineral capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
    VANADYL SULFATE (UNII: 6DU9Y533FA) (VANADIUM - UNII:00J9J9XKDE) VANADYL SULFATE15 mg
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE200 ug
    GYMNEMA SYLVESTRE LEAF (UNII: 2ZK6ZS8392) (GYMNEMA SYLVESTRE LEAF - UNII:2ZK6ZS8392) GYMNEMA SYLVESTRE LEAF100 mg
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) (ARGININE - UNII:94ZLA3W45F) ARGININE HYDROCHLORIDE60 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-13.5 mg
    PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE90 ug
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A900 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID50 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL18.75 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE8 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE4 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN24 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM1000 ug
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN8 ug
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID8 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    Colorgreen (Light Green with Brown Speckles) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-162-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/26/2024
    Labeler - PureTek Corporation (785961046)