TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0118-01, 0135-0118-04, 0135-0118-14, 0135-0118-83, 0135-0180-01, 0135-0180-02, 0135-0180-14, 0135-0181-01, 0135-0181-02, 0135-0181-03, 0135-0181-05, 0135-0181-06, 0135-0181-07, 0135-0181-14, 0135-0228-01, 0135-0228-04, 0135-0228-05, 0135-0228-06, 0135-0228-07, 0135-0540-01
Set ID f4786707-a0f7-4ba8-9656-06278d1b4b6c
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 1000 mg

  • Purpose

    Antacid

  • Uses

    relieves

    heartburn
    acid indigestion
    sour stomach
    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 7 tablets in 24 hours
    if pregnant do not take more than 5 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 2-3 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

    each tablet contains: elemental calcium 400mg, sodium 2mg
    store below 30oC (86oF)

     

  • 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 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 (Assorted Berry)

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

  • Inactive ingredient (Peppermint)

    corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredients (Peppermint Tri-Color)

    corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) 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.

    www.tums.com

    GlaxoSmithKline

    Moon Twp, PA 15108

    Gluten-Free

  • Principal Display Panel

    NDC 0135-0118-83

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    ASSORTED FRUIT

    ULTRA STRENGTH 1000

    72 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    ©2014 GSK

    PAREVE

    103662XA (Front Label)

    103593XA (Back Label)

    Tums Ultra Assorted Fruit 72 count front label
  • Principal Display Panel

    NDC 0135-0180-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    TROPICAL FRUIT

    ULTRA STRENGTH 1000

    72 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    ©2014 GSK

    PAREVE

    103634XA (Front Label)

    103591XA (Back Label)

    Tums Ultra Tropical Fruit 72 count front label
  • Principal Display Panel

    NDC 0135-0181-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    ASSORTED BERRIES

    ULTRA STRENGTH 1000

    72 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    ©2014 GSK

    PAREVE

    103665XA (Front Label)

    103588XA (Back Label)

    Tums Ultra Assorted Berries 72 count front label
  • Principal Display Panel

    NDC 0135-0228-06

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    PEPPERMINT

    ULTRA STRENGTH 1000

    72 CHEWABLE TABLETS

    GOES TO WORK IN SECONDS!

    ©2014 GSK

    103664XA (Front Label)

    103592XA (Back Label)

    Tums Ultra Peppermint 72 count front label
  • Principal Display Panel

    NDC 0135-0540-01

    TUMS®

    ANTACID

    CALICUM CARBONATE

    PEPPERMINT

    ULTRA STRENGTH 1000

    86 CHEWABLE TABLETS

    20% MORE FREE

    PAREVE

    ©2014 GSK

    104475XA (Front Label)

    104476XA (Back Label)

    Tums Ultra tricolor Peppermint 86 ct label
  • INGREDIENTS AND APPEARANCE
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorPINK (orange, yellow, green) Scoreno score
    ShapeROUNDSize19mm
    FlavorCHERRY (assorted fruit, orange, lemon, lime) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0118-0186 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    2NDC:0135-0118-04265 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    3NDC:0135-0118-14160 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    4NDC:0135-0118-8372 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/12/2010
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorORANGE (red-orange, cream to off-white, light yellow) Scoreno score
    ShapeROUNDSize19mm
    FlavorTROPICAL FRUIT PUNCH (assorted tropical fruit, mandarin orange, orange-pineapple, strawberry-banana) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0180-0186 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    2NDC:0135-0180-0272 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    3NDC:0135-0180-14160 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/12/2010
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0181
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorPINK (mauve, bluish) Scoreno score
    ShapeROUNDSize19mm
    FlavorBERRY (assorted berry, strawberry, raspberry, mixed berry) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0181-013 in 1 CARTON02/12/2010
    112 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:0135-0181-0272 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    3NDC:0135-0181-0312 in 1 PACKAGE; Type 0: Not a Combination Product02/12/2010
    4NDC:0135-0181-05265 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    5NDC:0135-0181-0686 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    6NDC:0135-0181-071 in 1 CARTON02/12/2010
    612 in 1 PACKAGE; Type 0: Not a Combination Product
    7NDC:0135-0181-14160 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/12/2010
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0228
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0228-0112 in 1 PACKAGE; Type 0: Not a Combination Product02/12/2010
    2NDC:0135-0228-0410 in 1 PACKAGE; Type 0: Not a Combination Product02/12/2010
    3NDC:0135-0228-05160 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    4NDC:0135-0228-0672 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    5NDC:0135-0228-0786 in 1 BOTTLE; Type 0: Not a Combination Product02/10/201504/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/12/2010
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0540
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorWHITE, RED, GREENScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0540-0186 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/12/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)