MULTIVITAMIN WITH FLUORIDE (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A, AND VITAMIN D) TA

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  • MULTIVITAMIN WITH FLUORIDE (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A, AND VITAMIN D) TA

MULTIVITAMIN WITH FLUORIDE (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, THIAMINE, VITAMIN A, AND VITAMIN D) TA
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NDC 44946-1025-1
Set ID 6f65379e-0c42-4451-bd42-7a050a4215cc
Category DIETARY SUPPLEMENT
Packager Sancilio & Company Inc
Generic Name
Product Class
Product Number
Application Number
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  • HEALTH CLAIM

    Each Multivitamin with 1.0 mg Fluoride Tablet Contains:
    *
    Each Multivitamin with 1.0 mg Fluoride Tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride (NaF).
    Vitamin A (as Acetate)2500 IU
    Vitamin C60 mg
    Vitamin D400 IU
    Vitamin E15 IU
    Thiamine1.05 mg
    Riboflavin1.2 mg
    Niacin13.5 mg
    Vitamin B61.05 mg
    Folate (as Folic Acid)0.3 mg
    Vitamin B124.5 mcg
    Fluoride (as Sodium Fluoride)*1.0 mg
  • WARNING

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

    DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

  • Directions

    USE AS DIRECTED BY YOUR PHYSICIAN.

  • Description

    Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "3" on the other.

  • Caution

    Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

  • Other Ingredients

    Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural fruit flavor, citric acid.

  • Storage

    Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.

  • HEALTH CLAIM

    This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

    The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

    Manufactured by: Sancilio & Co., Inc. Riviera Beach, FL 33404 USA

    rev. 11/18/11

  • PRINCIPAL DISPLAY PANEL - 1.0 mg Tablet Bottle Label

    Sancilio &
    Company, Inc.
    Developing Good Science into Great Medicine ™

    44946-1025-1

    Multivitamin
    with Fluoride
    Chewable Tablets

    NO DYES, ARTIFICIAL FLAVORS OR SUGAR
    SACCHARIN AND GLUTEN FREE
    CONTAINS XYLITOL

    1.0
    mg

    Dispensed only under the order of a
    physician or licensed medical
    practitioner†

    Dietary
    Supplement

    100 tablets

    PRINCIPAL DISPLAY PANEL - 1.0 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN WITH FLUORIDE 
    .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, sodium fluoride, folic acid, niacin, pyridoxine, riboflavin, thiamine, vitamin a, and vitamin d tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1025
    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-15 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin4.5 ug
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.3 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin13.5 mg
    Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
    Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A2500 [iU]
    Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D400 [iU]
    Inactive Ingredients
    Ingredient NameStrength
    Xylitol (UNII: VCQ006KQ1E)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    Mannitol (UNII: 3OWL53L36A)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium stearate (UNII: 70097M6I30)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Anhydrous Citric acid (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1025-1100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/20/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)13 mm
    imprint
    flavor
    Labeler - Sancilio & Company Inc (176681257)
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