Label: ROLAIDS EXTRA STRENGTH ANTACID MINT- calcium carbonate and magnesium hydroxide tablet, chewable

  • NDC Code(s): 69423-827-01, 69423-827-03, 69423-827-96
  • Packager: THE PROCTER & GAMBLE MANUFACTURING COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • Rolaids Extra Strength Mint

    Drug Facts

  • Active ingredient (in each tablet)

    Calcium carbonate USP 675 mg
    Magnesium hydroxide USP 135 mg

  • Purpose

    Antacid

    Antacid

  • Uses

    relieves:

    • heartburn
    • sour stomach
    • acid indigestion
  • Warnings

    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 10 tablets in a 24-hour period
    • do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

  • Directions

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

    each tablet contains:calcium 270 mg, magnesium 55mg

  • Inactive ingredients

    dextrose, flavor, magnesium stearate, maltodextrin, silicon dioxide, stearic acid, sucralose, sucrose

  • Tamper Evident

    Do not use if inner foil seal on bottle is broken or missing.

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER &

    GAMBLE, CINCINNATI, OH

    45202

  • PRINCIPAL DISPLAY PANEL

    EXTRASTRENGTH ANTACID
    Rolaids ®

    ANTACID

    GOES TO WORK INSTANTLY

    Mint Naturally & Artificially Flavored

    96 Chewable Tablets

    Mint

  • INGREDIENTS AND APPEARANCE
    ROLAIDS EXTRA STRENGTH ANTACID  MINT
    calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-827
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE675 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE135 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorMINTImprint Code R;X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-827-033 in 1 CELLO PACK01/01/2024
    1NDC:69423-827-0110 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:69423-827-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00101/01/2024
    Labeler - THE PROCTER & GAMBLE MANUFACTURING COMPANY (004238200)
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