TUMS EX (CALCIUM CARBONATE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

TUMS EX (CALCIUM CARBONATE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
PDF | XML

NDC 0135-0074-01, 0135-0074-06, 0135-0074-07, 0135-0074-22, 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
Set ID 593a0494-d669-4bcf-8412-b92645b2d76c
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART331
  • 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, 0135-0178)