Label: DRX CHOICE ANTACID CALCIUM REGULAR STRENGTH- calcium carbonate 500mg tablet, chewable

  • NDC Code(s): 68163-101-12, 68163-101-50
  • Packager: Raritan Pharmaceuticals 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 September 1, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 500mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    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 swallow tablets whole.
    •
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

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

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

  • Questions?

    1-866-467-2748

  • Principal Display Panel

    DRx CHOICE®

    *Compare to the active Ingredient in Regular Strength Tums®

    REGULAR STRENGTH

    Antacid Tablets

    CALCIUM CARBONATE 500 mg

    Fast Relief of Upset Stomach, Heartburn and Acid Indigestion.

    Assorted Fruit

    Naturally & Artificially Flavored

    GLUTEN-FREE

    Chewable Tablets 60

    K PAREVE

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®.

    Manufactured by: Raritan Pharmaceuticals

    8 Joanna Court, East Brunswick, NJ 08816

    Package label for 60ct Tablets

    DRx Choice Assorted Fruit Antacid 60 CT
  • Principal Display Panel

    Package label for 150ct Tablets

    DRx Choice R/S Antacid Tablets Assorted Fruit Flavor 150ct
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE ANTACID CALCIUM  REGULAR STRENGTH
    calcium carbonate 500mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, 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
    FlavorFRUIT (assorted) Imprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-101-1260 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    2NDC:68163-101-50150 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/17/2018
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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