Label: QUALITY CHOICE ULTRA STRENGTH ANTACID ASSORTED BERRY ULTRA STRENGTH ANTACID ASSORTED BERRY- calcium carbonate tablet, chewable

  • NDC Code(s): 63868-127-72
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 19, 2022

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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:
    • wet in mouth before chewing
    • chew 2-3 tablets as symptoms occur, or as directed by a doctor.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 400 mg, magnesium 10 mg
    • do not use if printed seal under cap is torn or missing
    • store below 30˚C (86˚F).
  • INACTIVE INGREDIENTS

    adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    NDC 63868-127-72
    QC 

     Quality Choice
    *Compare to the Active ingredient in Ultra Strength Tums® 

    Ultra Strength
    Antacid Tablets
    Calcium Carbonate 1000 mg

    Relieves:

    Heartburn
    Acid Indigestion

    Assorted Berry
    72 Chewable Tablets

    171AB-QC-72ct
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE ULTRA STRENGTH ANTACID ASSORTED BERRY  ULTRA STRENGTH ANTACID ASSORTED BERRY
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-127
    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 (UNII: 68401960MK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 Aluminum lake (UNII: J9EQA3S2JM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBLUE, PINK, PINK (PINKISH BLUE) Scoreno score
    ShapeROUNDSize17mm
    FlavorBERRY (STRAWBERRY, RASPBERRY, WIDBERRY) Imprint Code G171
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-127-7272 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33107/19/2022
    Labeler - Chain Drug Marketing Association Inc. (011920774)
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