Label: DRX CHOICE ANTACID CALCIUM ASSORTED BERRY- calcium carbonate 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 June 11, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (per tablet)

    Calcium Carbonate USP 1000mg

  • 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 7 tablets in 24 hours
    if pregnant do not take more than 5 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 2-3 tablets, completely 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: calcium 400mg
    store at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    adipic acid, dextrose, FD&C blue no. 1 Lake, FD&C Red no. 40 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

  • 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

    DRx Choice®

    NDC# 68163-103-65

    Compare to the active ingredient in Ultra Strength Tums® *

    ultra strength

    Antacid Tablets

    Calcium Carbonate 1000 mg

    Fast relief of upset stomach,

    heartburn & acid indigestion

    Assorted Berry

    Naturally & artificially flavored

    GLUTEN FREE

    265 chewable tablets

    K PAREVE

    Manufactured 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, Ultra Strength Tums®.

    DRx Choice Ultra Strength Antacid Tablets Calcium Carbonate 265 CT
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE ANTACID CALCIUM  ASSORTED BERRY
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED, PINK, PURPLE, BLUEScoreno score
    ShapeROUNDSize19mm
    FlavorBERRY (assorted berry) Imprint Code RP103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-103-65265 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/04/2021
    Labeler - Raritan Pharmaceuticals Inc (127602287)