Label: EXTRA STRENGTH 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 August 19, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750mg

  • 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 10 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 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 300mg
    •
    store at room temperature. Keep the container tightly closed.

    Inactive Ingredients

    adipic acid, dextrose, FD&C blue #1 lake, FD&C red # 40 lake, flavor, 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

    berkley jensen®

    NDC# 68391-102-00

    **Compare to the Active Ingredient in TUMs® Extra Strength

    Extra Strength

    ANTACID TABLETS

    ASSORTED BERRY FLAVORS

    FAST RELIEF OF:

    •
    ACID INDIGESTION
    •
    UPSET STOMACH
    •
    HEARTBURN

    200 CHEWABLE TABLETS

    K PAREVE

    Every Berkley Jensen product comes with our

    100% Money-Back Guarantee.

    Distributed by:

    BJ’S Wholesale Club,

    25 Research Drive,

    Westborough, MA 01581.

    Questions? 1-800-934-1204

    Made in USA

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

    Extra Strenhtg Antacid Tablets 200 counts
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH  ASSORTED BERRY
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 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 RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-102-00200 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/14/2019
    Labeler - BJWC (159082692)
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