Label: EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 14, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient (per tablet)

    Calcium Carbonate USP 750 mg

  • 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 9 tablets in 24 hours
    •
    If pregnant do not take more than 6 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 300 mg
    •
    store below 30°C (86°F).
  • Inactive ingredients

    adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6 lake.

    Questions or comments?

    1-866-467-2748

    SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • Package/Label Principal Display Panel

    NDC 68163-202-90

    DRxCHOICE®

    Compare to Tums® active ingredient*

    EXTRA STRENGTH

    Antacid

    Tablets

    Calcium Carbonate USP 750 mg

    Sugar-Free

     
    Relieves:
    •
    Acid Indigestion
    •
    Sour Stomach

    90 CHEWABLE TABLETS

    K PARVE

    Distributed by:

    Raritan Pharmaceuticals

    8 Joanna Court, East Brunswick, NJ 08816

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

    DRx Choice Extra Strength Antacid 90 CT Orange Cream Flavor
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SUGAR FREE  ORANGE CREAM FLAVOR
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize16mm
    FlavorORANGE (Cream) Imprint Code RP102SF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-202-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/18/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!