TUMS CHEWY DELIGHTS (CALCIUM CARBONATE) BAR, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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TUMS CHEWY DELIGHTS (CALCIUM CARBONATE) BAR, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0560-01, 0135-0560-02, 0135-0560-03, 0135-0561-01, 0135-0561-02, 0135-0561-03, 0135-0569-01
Set ID 189850d0-6f06-45bd-bd7e-9063ee580d0b
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each chew)

    Calcium carbonate USP 1177 mg

  • Purpose

    Antacid

  • Uses

    Relieves:

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
    •
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    •
    do not take more than 6 chews in 24 hours
    •
    if pregnant, do not take more than 4 chews in 24 hours
    •
    do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

    Keep out of reach of children.

  • Directions

    •
    adults and children 12 years of age and over: chew and swallow 2-3 chews as symptoms occur, or as directed by a doctor
    •
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    •
    each chew contains: elemental calcium 470 mg, magnesium 5 mg
    •
    do not store above 25°C (77°F)
  • Inactive ingredients (Smooth Peppermint)

    corn starch, corn syrup, corn syrup solids, FD&C blue #1, flavors, glycerin, gum arabic, hydrogenated coconut oil, non-fat dairy milk, potassium sorbate, propylene glycol, soy lecithin, sucrose

  • Inactive ingredients (Very Cherry)

    corn starch, corn syrup, corn syrup solids, FD&C red #40 lake, flavors, glycerin, hydrogenated coconut oil, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

  • Inactive ingredients (Orange Rush)

    corn starch, corn syrup, corn syrup solids, FD&C yellow #6 lake, flavors, glycerin, hydrogenated coconut oil, modified food starch, non-fat dairy milk, propylene glycol, soy lecithin, sucrose

  • Questions or Comments?

    1-800-897-7535 weekdays

  • Principal Display Panel

    NDC 0135-0561-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Chewy Delights®

    Smooth Peppermint

    ULTRA STRENGTH

    GOES TO WORK IN SECONDS!

    32 SOFT CHEWS INDIVIDUALLY WRAPPED

    FAST & TASTY

    HEARTBURN RELIEF

    DAIRY

    Tamper Evident: Do not use if packaging is torn or damaged.

    Distributed By:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    TUMS and logo device are trademarks of the GSK group of companies.

    ©2014 GSK group of companies.

    All Rights Reserved

    103608XA

    Tums Chewy Delights Smooth Peppermint 32 count card
  • Principal Display Panel

    NDC 0135-0560-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Chewy Delights®

    Very Cherry™

    ULTRA STRENGTH

    GOES TO WORK IN SECONDS!

    32 SOFT CHEWS INDIVIDUALLY WRAPPED

    FAST & TASTY

    HEARTBURN RELIEF

    DAIRY

    Tamper Evident: Do not use if packaging is torn or damaged.

    Distributed By:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    TUMS and logo device are trademarks of the GSK group of companies.

    ©2014 GSK group of companies.

    All Rights Reserved

    103614XA

    Tums Chewy Delights Very Cherry 32 count card
  • Principal Display Panel

    NDC 0135-0569-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Chewy Delights®

    Orange Rush™

    ULTRA STRENGTH

    GOES TO WORK IN SECONDS!

    32 SOFT CHEWS INDIVIDUALLY WRAPPED

    FAST & TASTY

    HEARTBURN RELIEF

    Tamper Evident: Do not use if packaging is torn or damaged.

    Distributed By:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township,

    PA 15108

    TUMS and logo device are trademarks of the GSK group of companies.

    103438XA

    Tums Chewy Delights Orange Rush 32 card
  • INGREDIENTS AND APPEARANCE
    TUMS  CHEWY DELIGHTS
    calcium carbonate bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0561
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1177 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    COW MILK (UNII: 917J3173FT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITE (off white with blue flecks) Scoreno score
    ShapeRECTANGLESize21mm
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0561-0132 in 1 BAG; Type 0: Not a Combination Product08/01/2013
    2NDC:0135-0561-026 in 1 PACKAGE; Type 0: Not a Combination Product08/01/2013
    3NDC:0135-0561-032 in 1 POUCH; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/01/2013
    TUMS  CHEWY DELIGHTS
    calcium carbonate bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1177 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    COW MILK (UNII: 917J3173FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeRECTANGLESize21mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0560-0132 in 1 BAG; Type 0: Not a Combination Product08/01/2013
    2NDC:0135-0560-026 in 1 PACKAGE; Type 0: Not a Combination Product08/01/2013
    3NDC:0135-0560-032 in 1 POUCH; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/01/2013
    TUMS  CHEWY DELIGHTS
    calcium carbonate bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0569
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1177 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    COW MILK (UNII: 917J3173FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeRECTANGLESize21mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0569-0132 in 1 BAG; Type 0: Not a Combination Product08/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/15/2014
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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