Label: TUMS CHEWY DELIGHTS- calcium carbonate bar, chewable

  • NDC Code(s): 0135-0560-01, 0135-0560-02, 0135-0560-03, 0135-0561-01, view more
    0135-0561-02, 0135-0561-03, 0135-0569-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 9, 2020

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

  • 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)