GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [GOODSENSE]

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GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [GOODSENSE]
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NDC 50804-171-68
Set ID ad4d51f6-b55b-45db-b034-fb3da54fbe99
Category Human OTC Drug Label
Packager GoodSense
Generic Name
Product Class
Product Number
Application Number PART331
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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 1000 mg

  • PURPOSE

    Antacid

  • USE(S)

    relieves:

    • acid indigestion
    • heartburn
  • WARNINGS

    .

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • WHEN USING THIS PRODUCT

    do not take more than 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • IF PREGNANT OR/BREASTFEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    .

  • DIRECTIONS

    • adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 400 mg
    • do not use if printed seal under cap is torn or missing
    • store at room temperature. keep the container tightly closed.
  • INACTIVE INGREDIENTS

    adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    GOODSENSE
    NDC 50804-171-68
    Ultra Strength
    Antacid
    TABLETS
    Calcium Carbonate 1000 mg

    Fast Relief of


    • Acid indigestion 
    • Heartburn
    • Upset stomach

    Assorted Fruit Flavors
     *Compare to the active ingredient of Ultra Strength Tums® 
    72 Chewable Tablets



    171
  • INGREDIENTS AND APPEARANCE
    GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGE, YELLOW, GREEN, PINK (reddish pink) Scoreno score
    ShapeROUNDSize17mm
    FlavorCHERRY, LEMON, LIME, ORANGEImprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-171-6872 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33108/08/2018
    Labeler - GoodSense (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(50804-171)
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