Label: DAVIMET- multivitamin tablet, chewable

  • 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 September 19, 2022

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

  • Each Chewable Tablet Contains:

    Vitamin A (as retinyl acetate)............................750 mcg RAE
    Vitamin C (as sodium ascorbate & ascorbic acid)........60 mg
    Vitamin D3 (as cholecalciferol)...................................10 mcg
    Vitamin E .....................................................................10 mg
    Thiamin (as thiamine mononitrate)...........................1.05 mg
    Riboflavin....................................................................1.2 mg
    Niacin (as niacinamide).............................................13.5 mg
    Vitamin B6 (as pyridoxine hydrochloride).................1.05 mg
    Folate (as folic acid).....1667 mcg DFE (1000 mcg folic acid)
    Vitamin B12 (as cyanocobalamin).............................4.5 mcg

  • Other Ingredients:

    Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake).

    Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.

  • INDICATIONS AND USAGE

    Davimet™ Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.

    Contraindications:

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

  • WARNING

    Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    CAUTION: Should be chewed.

  • 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.

  • Adverse Reactions:

    Folic Acid: Allergic sensitizations 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.

  • DOSAGE AND ADMINISTRATION

    One tablet daily, to be dissolved in the mouth or chewed before swallowing.

  • HOW SUPPLIED

    Multivitamin chewable tablets are light purple with speckles, grape flavor, un-scored, round tablets. Available on prescription only in
    bottles of 30 tablets – NDC 59088-695-54. Dispense in a tight, light resistant container with a child resistant closure as defined in the
    USP/NF. 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 controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
    Protect from light and moisture and avoid excessive heat.

  • Davimet™

    Manufactured in the USA by:
    PureTek Corporation

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

    label

  • INGREDIENTS AND APPEARANCE
    DAVIMET 
    multivitamin tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-695
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A750 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID24 mg
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN13.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1667 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    Colorpurple (Light Purple) Scoreno score
    ShapeROUNDSize13mm
    FlavorGRAPE (Grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-695-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/19/2022
    Labeler - PureTek Corporation (785961046)