Label: ANIMAL SHAPES- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin tablet, chewable

  • NDC Code(s): 76413-340-01
  • Packager: Central Texas Community Health Centers
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 18, 2017

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

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving % DV* % DV
    *
    % Daily Value (DV) for Children 2-3 years of age.
    % Daily Value (DV) for Adults and Children 4 or more years of age.
    Vitamin A (as Acetate) 2,500 I.U. 100% 50%
    Vitamin C (as Ascorbic Acid and Sodium Ascorbate) 60 mg. 150% 100%
    Vitamin D-3 (as Cholecalciferol) 400 I.U. 100% 100%
    Vitamin E (as dl-Alpha Tocopheryl Acetate) 15 I.U. 150% 50%
    Vitamin B-1 (as Thiamine Mononitrate) 1.05 mg. 150% 70%
    Vitamin B-2 (Riboflavin) 1.2 mg. 150% 70%
    Niacin (as Niacinamide) 13.5 mg. 150% 67%
    Vitamin B-6 (as Pyridoxine HCl) 1.05 mg. 150% 52%
    Folic Acid 0.3 mg. 150% 75%
    Vitamin B-12 (as Cyanocobalamin) 4.5 mcg. 150% 75%

    OTHER INGREDIENTS: Sorbitol, Sugar, Gelatin, Stearic Acid, Citric Acid, Silica, Unsaturated Mono & Diglycerides, Starch, Magnesium Stearate, Cherry Flavor, Orange Flavor, Grape Flavor, Microcrystalline Cellulose, FD&C Red #40 Lake, Sucralose, FD&C Yellow #6 Lake, Dicalcium Phosphate, Sodium Ascorbate, FD&C Blue #2 Lake, Triglycerides, Sodium Benzoate, Tocopherols, Sorbic Acid and BHT.

    Cherry flavor contains: Modified Corn Starch Grape flavor contains: Maltodextrin, Modified Corn Starch and Silica Orange flavor contains: Maltodextrin, Lactose1, Natural Flavoring, Modified Corn Starch and Sugar


    1
    Contains: Milk
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  • DIRECTIONS

    For adults and children 2 years of age and older, chew one (1) tablet daily, preferably with a meal. As a reminder, discuss the supplements and medications you take with your health care providers.

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  • WARNING

    If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. THIS PRODUCT IS INTENDED FOR USE BY CHILDREN UNDER ADULT SUPERVISION.

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  • SAFE HANDLING WARNING

    KEEP OUT OF THE REACH OF CHILDREN. STORE AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT. TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

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  • HEALTH CLAIM

    Distributed by: MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive, Livonia, MI 48150, USA
    Questions or Comments? (800) 616-2471

    M-29
    11382-06-16
    Rev. 06/16

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Austin/Travis Co. Health & Human Services Dept.

    MVI
    Animal
    Shapes
    Chewable
    tab

    Date:

    Name:
    Dr.

    Take as directed on package.

    01/01/01

    123456

    MVI Animal Shapes Chewable tab #100 NDC 76413-340-01

    Batch:
    123456
    Lot:
    123456
    Exp:
    01/01/01

    MAJOR

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ANIMAL SHAPES 
    vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, and cyanocobalamin tablet, chewable
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:76413-340
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU]
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 15 [iU]
    Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.2 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 13.5 mg
    Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine 1.05 mg
    Folic acid (UNII: 935E97BOY8) (Folic acid - UNII:935E97BOY8) Folic acid 0.3 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 4.5 ug
    Inactive Ingredients
    Ingredient Name Strength
    Sorbitol (UNII: 506T60A25R)  
    Sucrose (UNII: C151H8M554)  
    Gelatin, Unspecified (UNII: 2G86QN327L)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
    Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
    sodium ascorbate (UNII: S033EH8359)  
    FD&C Blue NO. 2 (UNII: L06K8R7DQK)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Tocopherol (UNII: R0ZB2556P8)  
    Sorbic acid (UNII: X045WJ989B)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:76413-340-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 06/01/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    color
    color
    scoring 1
    shape
    size (solid drugs) 1 mm
    flavor
    flavor
    flavor
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    Name Address ID/FEI Business Operations
    Central Texas Community Health Centers 079674019 REPACK, RELABEL
    Establishment
    Name Address ID/FEI Business Operations
    Major Pharmaceuticals 383359612 MANUFACTURE
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