Label: ROLAIDS ULTRA STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate, magnesium hydroxide tablet, chewable

  • NDC Code(s): 69423-825-10, 69423-825-72
  • Packager: THE PROCTER & GAMBLE MANUFACTURING COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Ultra Strength Rolaids Antacid, Assorted Fruit Chewable Tablets

    Drug Facts

  • Active ingredient

    (in each tablet)
    Calcium carbonate USP 1000 mg
    Magnesium hydroxide USP 200 mg

  • Purpose

    Antacid

    Antacid

  • Uses

    for the relief of:

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • 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 7 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 2-3 tablets as symptoms occur, or as directed by a doctor
  • Other information

    each tablet contains: calcium 400 mg, magnesium 85mg

    • store at room temperature 20°-25°C (68°-77°F)
    • contains FD&C yellow no.5 (tartrazine) as color additive
    • contains FD & C yellow no.6
  • Inactive ingredients

    acacia, corn starch, corn syrup, dextrose, FD&C red no. 40 lake, FD&C yellow no. 5 lake, FD&C yellow no. 6 lake, fructose*, lactose, magnesium stearate, maltodextrin, medium chain triglycerides, natural and artificial flavor, propylene glycol alginate, silicon dioxide, stearic acid, sucralose, sucrose, tocopherols, triacetin

    *May contain this ingredient

  • Questions?

    1-833-372-2729

  • Tamper Evident

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

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL

    ULTRA STRENGTH
    Rolaids ®ANTACID

    GOES TO WORK INSTANTLY
    Assorted Fruit
    72 Chewable Tablets

    Assorted Fruit

  • INGREDIENTS AND APPEARANCE
    ROLAIDS ULTRA STRENGTH ANTACID  ASSORTED FRUIT
    calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-825
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ACACIA (UNII: 5C5403N26O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIACETIN (UNII: XHX3C3X673)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorred, yellow, orangeScoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (cherry, lemon, orange) Imprint Code R;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-825-1010 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2024
    2NDC:69423-825-7272 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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