Label: CALCIUM CARBONATE ASSORTED FLAVORS- antacid tablets tablet, chewable

  • 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 January 20, 2022

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  • Active ingredient

    Calcium Carbonate USP 500mg

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn

    • sour stomach

    • acid indigestion

    • upset stomach associated with these symptoms

  • 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 15 tablets in 24 hours
    • If pregnant do not take more than 10 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
  • Keep out of Reach of Children

  • Directions

    • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
    • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
  • Other Information

    • each tablet contains: elemental calcium 200 mg
    • Store at room temperature. Keep the container tightly closed

    Safety sealed: Do not use if printed seal under cap is torn or missing.

  • Inactive ingredients

    adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

  • Package/Label Principal Display Panel

    pdp

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  ASSORTED FLAVORS
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2258(NDC:0904-6412)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorFRUITImprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-2258-5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/12/2014
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-2258)
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