RAZZMATAZZ ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [PROVISION MEDICAL PRODUCTS]

RAZZMATAZZ ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [PROVISION MEDICAL PRODUCTS]
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NDC 69103-2516-5, 69103-2516-6
Set ID 621fe3eb-1ef2-4272-9482-a53a7aaa32f5
Category HUMAN OTC DRUG LABEL
Packager Provision Medical Products
Generic Name
Product Class
Product Number
Application Number PART331
  • INDICATIONS & USAGE

    UseS

    For the relief of-Sour Stomach, Upset Stomach, Heartburn, Acid Indigestion

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health

    professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In

    case of overdose, get medical help or

    contact a Poison Control Center right

    away.

    Prompt medical attention is critical for adults as

    well as for children, even if you do not notice any signs

    or symptoms.

  • WARNINGS

    Warnings:

    Ask a doctor or health professional before use if you are:

    currently taking a prescription drug. Antacids may react

    with certain prescription drugs.

  • DOSAGE & ADMINISTRATION

    Directions:Do not use more thsn directed.  Adults and children 12 years or older.

    Take 2 tablets every 4 to 6 hours or as needed,

    do not exceed 18 tablets in 24 hours, or as

    directed by a doctor. 

    Children under 12 years-Do not give to children under 12 years unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    corn startch, FD&C Red 40, flavor,

    magnesium stearate,

    silicon dioxide, startch,

    sucrose

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-calcium carbonate 420 MG

  • PURPOSE

    ANTACID

  • PRINCIPAL DISPLAY PANEL

    RASPBERRY ANTACID BOX

  • INGREDIENTS AND APPEARANCE
    RAZZMATAZZ ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2516
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (WHITE WITH GREEN FLECKS) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2516-5250 in 1 CARTON03/31/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2516-6100 in 1 CARTON03/31/2015
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/31/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultraseal Corporation085752004pack(69103-2516)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-2516)

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