Label: EXTRA STRENGTH 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 October 3, 2023

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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

    Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warningd.ca.gov

    Ask a doctor or pharmacist before use if you are

    •
    taking a prescription drug. Antacids may interact with certain prescription drugs
    •
    If you are 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: magnesium 31 mg, sodium 19 mg
    •
    Store at room temperature.
  • Inactive ingredients

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

  • Principal Display Panel

    LEADER™

    NDC 70000-0234-1

    COMPARE TO GAVISCON® EXTRA STRENGTH ANTACID active ingredients*

    Extra Strength

    Antacid Tablets

    Aluminum Hydroxide, 160 mg

    Magnesium Carbonate, 105 mg

    Original Flavor

     
    Helps Keep Acid Down for Hours
     
    Fast-Acting Heartburn Relief

    100 Chewable Tablets

    100% Money Back Guarantee

     
    DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    ©2018 Cardinal Health. All Right Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered

    trademarks of Cardinal Health. All other marks are the property of their respective owners.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

    All LEADER™ Brand Products Have A 100% Money Back Guarantee. Return to place of purchase if not satisfied.

    This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademarks of Gaviscon® Extra Strength Antacid.

    Extra Strength Original Flavor Antacid Tablets Aluminum Hydroxide, Magnesium Carbonate
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ANTACID  ORIGINAL FLAVOR
    aluminum hydroxide and magnesium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0234
    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:70000-0234-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/04/2019
    Labeler - Cardinal Health (063997360)
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