Label: HEALTHY ACCENTS ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredient (in each tablet)

    Calcium carbonate USP 500mg

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  • Purpose

    Antacid

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  • Uses

    relieves

    heartburn
    sour stomach
    acid indigestion
    upset stomach associated with these symptoms
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  • Warnings

    Ask a doctor before use if you have

    kidney stones
    a calcium-restricted diet

    Ask a doctor or pharmacist before use if you are

    now 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
    do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

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  • Directions

    chew 2 - 4 tablets as symptoms occur, or as directed by a doctor
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  • Other information

    each tablet contains: calcium 215 mg and magnesium 5 mg
    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    dextrose, flavor, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, talc

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  • Questions?

    1-866-322-2439

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  • Principal Display Panel

    regular strength

    antacid tablets

    antacid/calcium supplement

    calcium carbonate 500mg

    Compare to Tums® Regular Strength active ingredient

    peppermint

    naturally & artificially flavored

    Antacid Tablets Front Label
    Antacid Tablets Back Label
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  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55316-485
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CARBONATE ION and CALCIUM CATION) CALCIUM CARBONATE 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE  
    MALTODEXTRIN  
    MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    POWDERED CELLULOSE  
    TALC  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 17mm
    Flavor PEPPERMINT Imprint Code L485
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-485-47 150 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/21/2012
    Labeler - DZA Brands LLC (090322194)
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