Label: FAST ACTING HEARTBURN RELIEF PEPPERMINT FLAVOR- calcium carbonate tablet, chewable

  • NDC Code(s): 68163-011-00
  • 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 August 16, 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 older: 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 200mg
    •
    store at room temperature. Keep the container tightly closed
  • Inactive ingredients

    Gum acacia, magnesium stearate, microcrystalline cellulose, natural peppermint oil, polyplasdone, sucrose.

    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 68163-011-00

    *COMPARE TO THE ACTIVE INGREDIENT IN REGULAR STRENGTH TUM®

    FAST ACTING

    HEARTBURN RELIEF

    FOR FAST RELIEF OF:

    ACID INDIGESTION, SOUR STOMACH & HEARTBURN

    PEPPERMINT FLAVOR

    GLUTEN FREE

    100 CHEWABLE TABLETS

    KOSHER FOR PASSOVER

    This product does not contain any Chometz or Kitnius

    This product contains no animal soybean, or grain derivatives.

    Manufactured for: Adwe Laboratories

    1274 49 Street, Brooklyn, NY 11219

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

    Fast Acting Heartburn Relief Antacid 100 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    FAST ACTING HEARTBURN RELIEF  PEPPERMINT FLAVOR
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-011
    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
    ACACIA (UNII: 5C5403N26O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-011-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/22/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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