ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE ROLAIDS ULTRA STRENGTH ANTACID ORANGE (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET

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  • ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE ROLAIDS ULTRA STRENGTH ANTACID ORANGE (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET

ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE ROLAIDS ULTRA STRENGTH ANTACID ORANGE (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET
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NDC 41167-1030-1, 41167-1031-1, 41167-1031-2
Set ID f4a91efc-2d81-4605-8178-d36ab6c71563
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • SPL UNCLASSIFIED SECTION

    ULTRA STRENGTH ANTACID Rolaids Softchews- Strawberry

    Drug Facts

  • Active ingredients

    (in each chew)
    Calcium carbonate USP 1330 mg
    Magnesium hydroxide USP 235 mg

  • Purpose

    Antacid
    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 5 chews 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 chews as symptoms occur, or as directed by a doctor  
  • Other information

    each tablet contains: calcium 535 mg, magnesium 100 mg

  • Inactive ingredients

    corn starch, corn syrup, corn syrup solids, glycerin, hydrogenated coconut oil, lecithin, natural and artificial flavors, red 40 lake, sucrose, water (309-099)

    ULTRA STRENGTH ANTACID Rolaids Softchews- Orange

    Drug Facts

  • Active ingredients

    (in each chew)
    Calcium carbonate USP 1330 mg
    Magnesium hydroxide USP 235 mg

  • Purpose

    Antacid
    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 5 chews 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 chews as symptoms occur, or as directed by a doctor  
  • Other information

    each tablet contains: calcium 535 mg, magnesium 100 mg

  • Inactive ingredients

    corn starch, corn syrup, corn syrup solids, glycerin, hydrogenated coconut oil, lecithin, natural and artificial flavors, sucrose, water. yellow 6 lake (309-100)

  • PRINCIPAL DISPLAY PANEL

    ULTRA STRENGTH ANTACID
    Rolaids®
    Softchews
    6 Strawberry Chews

    ULTRA STRENGTH ANTACID Rolaids® Softchews 6 Strawberry Chews

  • PRINCIPAL DISPLAY PANEL

    ULTRA STRENGTH ANTACID
    Rolaids®
    Softchews
    6 Orange Chews

    ULTRA STRENGTH ANTACID Rolaids® Softchews 6 Orange Chews

  • INGREDIENTS AND APPEARANCE
    ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY 
    calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1330 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE235 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeRECTANGLESize20mm
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1031-11 in 1 CARTON12/01/2014
    16 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:41167-1031-22 in 1 PACKAGE; Type 0: Not a Combination Product12/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/01/2014
    ROLAIDS ULTRA STRENGTH ANTACID ORANGE 
    calcium carbonate and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION1330 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE235 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeRECTANGLESize20mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1030-71 in 1 CARTON12/01/201411/05/2020
    16 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/01/201411/05/2020
    Labeler - Chattem, Inc. (003336013)
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