Label: CVS HEALTH EXTRA STRENGTH HEARTBURN RELIEF ANTACID ORIGINAL FLAVOR- aluminum hydroxide and magnesium 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 September 7, 2019

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  • Active ingredients (in each tablet)

    Aluminum hydroxide 160 mg

    Magnesium carbonate 105 mg

  • Purpose

    Antacid

    Antacid

  • Uses

    relieves

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

    Ask a doctor or pharmacist before use if you are

    ▪
    taking a prescription drug. Antacids may interact with certain prescription drugs
    ▪
    on a sodium-restricted diet

    When using this product

    ▪
    do not take more than 16 tablets in 24 hours
    ▪
    do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.1-800-222-1222

  • Directions

    ▪
    chew 2 to 4 tablets four times a day or as directed by a doctor
    ▪
    take after meals and at bedtime or as needed
    ▪
    for best results follow by a half glass of water or other liquid
    ▪
    DO NOT SWALLOW WHOLE
  • Other information

    ▪
    Each tablet contains: sodium 19 mg, magnesium 31 mg
    ▪
    Store at up to 25°C (77°F) in a dry place
  • Inactive ingredients

    alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    CVS Health™

    Compare to the active ingredients in Gaviscon®*

    NDC 59779-880-78

    EXTRA STRENGTH

    Heartburn Relief

    ANTACID

    •
    Fast-Acting heartburn relief
    •
    Helps keep acid down for hours

    Original Flavor

    100 CHEWABLE TABLETS

    Do not use if printed seal under cap is torn or missing

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive,

    Woonsocket, RI 02895

    ©2015 CVS/pharmacy

    CVS.com®

    1-800-SHOP CVS

    CVS® Quality

    Money Back Guarantee

    *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Gaviscon® Extra Strength.

    CVS Health Extra Strength Heartburn Relief Antacid Original Flavor 100 Chewable Tablets

    .

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH EXTRA STRENGTH HEARTBURN RELIEF ANTACID  ORIGINAL FLAVOR
    aluminum hydroxide and magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-880
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE160 mg
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE105 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize17mm
    FlavorBUTTERSCOTCH (ORIGINAL) Imprint Code RP105
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-880-78100 in 1 BOTTLE; Type 0: Not a Combination Product08/27/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/27/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
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