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

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TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0243-02, 0135-0245-02, 0135-0246-01, 0135-0246-02, 0135-0246-05, 0135-0246-07, 0135-0456-01, 0135-0456-03, 0135-0456-04, 0135-0456-05
Set ID c22944b8-8733-4689-be0c-f320467f79ea
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 (per tablet)

    Calcium Carbonate USP 750 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 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.

  • 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

    •
    each tablet contains: elemental calcium 300mg
    •
    store below 25oC (77oF). Keep the container tightly closed.
  • Inactive ingredients (Assorted Fruit)

    adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

    Contains: soy

  • Inactive ingredients (Berry Fusion)

    adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

    Contains: soy

  • Inactive ingredient (Assorted Tropical Fruit)

    adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

    Contains: soy

  • Inactive ingredients (Peppermint)

    corn starch, dextrose, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

  • Questions?

    1-800-897-7535 weekdays

  • Principal Display Panel

    NDC 0135-0246-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    SmoothiesTM

    Assorted Fruit

    SMOOTH DISSOLVE

    EXTRA STRENGTH 750

    GOES TO WORK IN SECONDS!

    60 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

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

    GlaxoSmithKline

    Moon Twp, PA 15108

    Gluten-Free

    www.tums.com

    Front Panel 103644XA

    Back Panel 103553XA

    Tums Smoothies Assorted Fruit 60 count front label
  • Principal Display Panel

    NDC 0135-0456-03

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    SmoothiesTM

    Berry Fusion

    SMOOTH DISSOLVE

    EXTRA STRENGTH 750

    GOES TO WORK IN SECONDS!

    60 CHEWABLE TABLETS

    PAREVE

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

    GSK CH

    Warren, NJ 07059

    Gluten-Free

    ©2014 GSK

    Front Panel 103680XA

    Back Panel 103725XA

    Tums Smoothies Berry Fusion 60 count front label
  • Principal Display Panel

    NDC 0135-0245-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    SmoothiesTM

    Tropical Fruit

    SMOOTH DISSOLVE

    EXTRA STRENGTH 750

    GOES TO WORK IN SECONDS!

    60 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

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

    GlaxoSmithKline

    Moon Twp, PA 15108

    Gluten-Free

    www.tums.com

    Front Panel 103818XA

    Back Panel 103816XA

    Tums Smoothies Tropical Fruit 60 count front label
  • Principal Display Panel

    NDC 0135-0243-02

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    SmoothiesTM

    Peppermint

    SMOOTH DISSOLVE

    EXTRA STRENGTH 750

    GOES TO WORK IN SECONDS!

    60 CHEWABLE TABLETS

    PAREVE

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

    Trademarks are owned by or licensed to the GSK group of companies.

    GSK Consumer Healthcare

    Warren, NJ 07059

    Gluten-Free

    ©2015 GSK or its licensor.

    Front Panel 103728XB

    Back Panel 103727XB

    Tums Smoothies Peppermint 60 count front label
  • INGREDIENTS AND APPEARANCE
    TUMS  SMOOTHIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0246
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    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)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINK (orange, dark pink, yellow) Scoreno score
    ShapeROUNDSize19mm
    FlavorCHERRY (Assorted flavor, orange, strawberry, lemon) Imprint Code TUMS;SD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0246-0112 in 1 CELLO PACK; Type 0: Not a Combination Product03/24/2010
    2NDC:0135-0246-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    3NDC:0135-0246-05140 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2014
    4NDC:0135-0246-07250 in 1 BOTTLE; Type 0: Not a Combination Product01/26/2016
    5NDC:0135-0246-0472 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/24/2010
    TUMS  SMOOTHIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0456
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorPINK (mauve, peach, dark pink) Scoreno score
    ShapeROUNDSize19mm
    FlavorCHERRY (Berry Fusion, citrus berry, orange passion, strawberry) Imprint Code TUMS;SD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0456-0112 in 1 CELLO PACK; Type 0: Not a Combination Product03/24/2010
    2NDC:0135-0456-0360 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    3NDC:0135-0456-0472 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    4NDC:0135-0456-05140 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/24/2010
    TUMS  SMOOTHIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0245
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorORANGE (peach, mauve) Scoreno score
    ShapeROUNDSize19mm
    FlavorORANGE (Assorted Tropical Fruit, orange passion, citrus berry, mixed fruit) Imprint Code TUMS;SD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0245-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/24/2010
    TUMS  SMOOTHIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0243
    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)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code TUMS;SD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0243-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/24/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutri Granulations017130076API MANUFACTURE(0135-0246, 0135-0456, 0135-0245, 0135-0243)
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