ROLAIDS ULTRA STRENGTH MINT (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]

ROLAIDS ULTRA STRENGTH MINT (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]
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NDC 41167-1003-1, 41167-1003-2, 41167-1003-3, 41167-1003-4, 41167-1003-5
Set ID 8806c912-ab83-4f45-ac78-e826bb3143d4
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
  • SPL UNCLASSIFIED SECTION

    ULTRA Strength Antacid Rolaids Mint 72 Chewable Tablets

    Drug Facts

  • Active ingredient

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

  • Purpose

    Antacid

  • Use

    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 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 85 mg

  • Inactive ingredients

    dextrose, flavor, magnesium stearate, silicon dioxide, stearic acid, sucralose, sucrose (309-055)

    As a daily source of calcium and magnesium, chew 2 tablets twice daily.

    Supplement Facts
    Serving Size: 2 Tablets, Servings Per Container: 36, Amount Per Serving: Calories 12, Total Carb 2 g (<1% DV*), Sugars 2 g (†DV), Calcium 800 mg (54% DV), Magnesium 170 mg (29% DV). *Percent Daily Values (DV) are based on a 2,000 calories diet.
    †Daily Value not established.
  • Other ingredients

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


  • PRINCIPAL DISPLAY PANEL

    ULTRA STRENGTH
    Rolaids®
    ANTACID
    Rapid Relief of:
    Heartburn
    Acid Indigestion
    72 Chewable Tablets
    Mint

    PRINCIPAL DISPLAY PANEL
ULTRA STRENGTH 
Rolaids®
ANTACID
Rapid Relief of:
Heartburn
Acid Indigestion
72 Chewable Tablets
Mint

  • INGREDIENTS AND APPEARANCE
    ROLAIDS ULTRA STRENGTH MINT 
    calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1003
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorMINTImprint Code R;U
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1003-172 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    2NDC:41167-1003-287 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    3NDC:41167-1003-3160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    4NDC:41167-1003-53 in 1 CELLO PACK09/01/2013
    4NDC:41167-1003-410 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33109/01/2013
    Labeler - Chattem, Inc. (003336013)

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