Label: TUMS EX- calcium carbonate tablet

  • NDC Code(s): 0135-0074-01, 0135-0074-06, 0135-0074-07, 0135-0074-22, view more
    0135-0074-24, 0135-0074-25, 0135-0074-46, 0135-0074-47, 0135-0076-01, 0135-0076-25, 0135-0076-26, 0135-0140-01, 0135-0140-02, 0135-0140-03, 0135-0140-05, 0135-0140-10, 0135-0154-02, 0135-0154-05, 0135-0178-01, 0135-0178-02, 0135-0178-03, 0135-0178-05, 0135-0178-08, 0135-0178-09, 0135-0521-01, 0135-0521-02
  • 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 12, 2018

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750 mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • Warnings (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry)

    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 10 tablets in 24 hours
    •
    if pregnant do not take more than 6 tablets 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.

  • Warnings (Sugar Free Orange Cream)

    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 9 tablets in 24 hours
    •
    if pregnant do not take more than 6 tablets 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 2 – 4 tablets 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 (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry)

    •
    each tablet contains: elemental calcium 300mg, sodium 2mg
    •
    store below 30°C (86°F)
  • Other information (Orange Cream)

    •
    each tablet contains: elemental calcium 300mg
    •
    store below 30°C (86°F)

    Phenylketonurics: Contains phenylalanine, less than 1mg per tablet.

  • Inactive ingredients (Assorted Fruit)

    adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredients (Assorted Berries)

    adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredients (Sugar Free Orange Cream)

    acacia, adipic acid, aspartame, calcium stearate, FD&C yellow #6 lake, flavors, sorbitol

  • Inactive ingredient (Assorted Tropical Fruit)

    corn starch, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredients (Wintergreen)

    corn starch, FD&C blue #1 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredients (Cherry)

    adipic acid, corn starch, FD&C red #40 lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

  • Questions?

    1-800-897-7535weekdays

    Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

    Gluten-Free

    www.tums.com

    GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    NDC 0135-0074-25

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Assorted Fruit

    EXTRA STRENGTH 750

    96 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103703XA

    Back Label: 103589XA

    Tums Extra Strength Assorted Fruit 96 count front label
  • Principal Display Panel

    NDC 0135-0178-03

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Assorted Berries

    EXTRA STRENGTH 750

    96 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103663XA

    Back Label: 103590XA

    Tums Extra Strength Assorted Berries 96 count front label
  • Principal Display Panel

    NDC 0135-0154-05

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Sugar-Free Orange

    EXTRA STRENGTH 750

    80 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103720XA

    Back Label: 103719XA

    Tums Extra Strength Sugar Free Orange 80 count front label
  • Principal Display Panel

    NDC 0135-0140-03

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Tropical Fruit

    EXTRA STRENGTH 750

    96 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103704XA

    Back Label: 103705XA

    Tums Extra Strength Tropical Fruit 96 count front label
  • Principal Display Panel

    NDC 0135-0076-25

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Wintergreen

    EXTRA STRENGTH 750

    96 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103707XA

    Back Label: 103708XA

    Tums Extra Strength Wintergreen 96 count front label
  • Principal Display Panel

    NDC 0135-0521-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Cherry

    EXTRA STRENGTH 750

    96 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    PAREVE

    ©2014 GSK

    Front Label: 103710XA

    Back Label: 103711XA

    Tums Extra Strength Cherry 96 count front label
  • INGREDIENTS AND APPEARANCE
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0074
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK, ORANGE, YELLOW, GREENScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRY (Assorted fruit flavor, orange, lemon, lime) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0074-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    2NDC:0135-0074-2248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    3NDC:0135-0074-243 in 1 CELLO PACK01/18/2010
    38 in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:0135-0074-2596 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    5NDC:0135-0074-468 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
    6NDC:0135-0074-0670 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    7NDC:0135-0074-07330 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    8NDC:0135-0074-473 in 1 PACKAGE10/15/2017
    896 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/18/2010
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0178
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK, RED (mauve) , BLUE (bluish) Scoreno score
    ShapeROUNDSize16mm
    FlavorSTRAWBERRY (Assorted Berry, raspberry, mixed berry) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0178-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/201004/30/2019
    2NDC:0135-0178-09200 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    3NDC:0135-0178-088 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
    4NDC:0135-0178-0570 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    5NDC:0135-0178-0248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    6NDC:0135-0178-0396 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/18/2010
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0154
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGE (orange cream) Scoreno score
    ShapeROUNDSize16mm
    FlavorORANGE (ORANGE CREAM) Imprint Code TUMS;FREE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0154-0296 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    2NDC:0135-0154-0580 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/18/2010
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorRED (red-orange) , ORANGE, WHITE (cream) , YELLOW (light yellow) Scoreno score
    ShapeROUNDSize16mm
    FlavorTROPICAL FRUIT PUNCH (Assorted tropical fruit flavor, tropical punch, mandarin orange, orange-pineapple, strawberry-banana) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0140-05116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    2NDC:0135-0140-0396 in 1 BOTTLE; Type 0: Not a Combination Product01/18/201009/30/2018
    3NDC:0135-0140-018 in 1 PACKAGE; Type 0: Not a Combination Product01/18/2010
    4NDC:0135-0140-10330 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    5NDC:0135-0140-0248 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/18/2010
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0076
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0076-01116 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    2NDC:0135-0076-2596 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    3NDC:0135-0076-2670 in 1 BOTTLE; Type 0: Not a Combination Product01/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/18/2010
    TUMS  EX
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0521
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0521-018 in 1 PACKAGE; Type 0: Not a Combination Product03/23/2011
    2NDC:0135-0521-0296 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/23/2011
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    GlaxoSmithKline Consumer Healthcare LP832116797LABEL(0135-0074)
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