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 January 26, 2024

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!