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

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ROLAIDS EXTRA STRENGTH FRUIT (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]
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NDC 41167-1002-0, 41167-1002-1, 41167-1002-2, 41167-1002-3, 41167-1002-4
Set ID ce2af1a6-0387-41e5-ad06-85b790bd4120
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • SPL UNCLASSIFIED SECTION

    Extra Strength Antacid Rolaids Assorted Fruit 10 Chewable Tablets

    Drug Facts

  • Active ingredient

    (in each tablet)
    Calcium carbonate USP 675 mg
    Magnesium hydroxide USP 135 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 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 55 mg

    • contains FD&C yellow no. 5 (tartrazine)
  • Inactive ingredients

    blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-060)

    Dist. by CHATTEM, INC.
    P.O. Box 2219
    Chattanooga, TN 37409

    Extra Strength Antacid Rolaids Assorted Fruit 96 Chewable Tablets

    Drug Facts

  • Active ingredient

    (in each tablet)
    Calcium carbonate USP 675 mg
    Magnesium hydroxide USP 135 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 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 55 mg
    • contains FD&C yellow no. 5 (tartrazine) as a color additive
  • Inactive ingredients

    blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-056)

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

    Supplement Facts
    Serving Size: 2 Tablets, Servings Per Container: 48, Amount Per Serving: Calories 8, Total Carb 2 g (<1% DV*), Sugars 2 g (†DV), Calcium 540 mg (54% DV), Magnesium 110 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, natural and artificial flavors, red 40 lake, yellow 6 lake, yellow 5 lake, blue 1 lake, sucralose

    Extra Strength Antacid Rolaids Assorted Fruit 30 Chewable Tablets

    Drug Facts

  • Active ingredient

    (in each tablet)
    Calcium carbonate USP 675 mg
    Magnesium hydroxide USP 135 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 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 55 mg
    • contains FD&C yellow no. 5 (tartrazine) as a color additive
  • Inactive ingredients

    blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose, yellow 5 lake, yellow 6 lake (309-060)

    Dist. by CHATTEM, INC.
    P.O. Box 2219
    Chattanooga, TN 37409

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH ANTACID
    Rolaids®
    10 Assorted Fruit Chewable Tablets

    EXTRA STRENGTH ANTACID Rolaids® 10 Assorted Fruit Chewable Tablets

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH
    Rolaids®
    ANTACID/ CALCIUM & MAGNESIUM SUPPLEMENT
    Goes to Work
    INSTANTLY 
    96 Chewable Tablets
    Assorted Fruit

    EXTRA STRENGTH Rolaids® ANTACID/ CALCIUM & MAGNESIUM SUPPLEMENT Goes to Work INSTANTLY 96 Chewable Tablets Assorted Fruit

  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH
    Rolaids®
    ANTACID
    Rapid Relief of:
    Heartburn
    Acid Indigestion
    3 Rolls
    30 Chewable Tablets
    Assorted Fruit 

    PRINCIPAL DISPLAY PANEL EXTRA STRENGTH Rolaids® ANTACID Rapid Relief of: Heartburn Acid Indigestion 3 Rolls 30 Chewable Tablets Assorted Fruit

  • INGREDIENTS AND APPEARANCE
    ROLAIDS EXTRA STRENGTH FRUIT 
    calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1002
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    Product Characteristics
    ColorRED, PURPLE, YELLOW, ORANGEScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (cherry, grape, lemon, orange) Imprint Code R;X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1002-0120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    2NDC:41167-1002-196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    3NDC:41167-1002-2116 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    4NDC:41167-1002-33 in 1 CELLO PACK09/01/2013
    4NDC:41167-1002-410 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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