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

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TUMS (CALCIUM CARBONATE) TABLET [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0070-03, 0135-0070-27, 0135-0070-48, 0135-0071-27, 0135-0071-48
Set ID 35f79dcf-1743-4d9f-aba5-5ead6b056309
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 500 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

    taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    •
    do not take more than 15 tablets in 24 hours
    •
    if pregnant do not take more than 10 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 200mg
    •
    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 ingredient (peppermint)

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

  • Questions?

    1-800-897-7535

    weekdays

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

    Gluten-Free

    www.tums.com

    GlaxoSmithKline

    Moon Twp, PA 15108

  • PRINCIPAL DISPLAY PANEL

    NDC 0135-0071-27

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    REGULAR STRENGTH 500

    Goes to Work in Seconds!

    Assorted Fruit

    150 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

    Front Label: 103784XA

    Back Label: 103783XA

    Tums Regular Assorted Fruit 150 count label
  • Principal Display Panel

    NDC 0135-0070-27

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    REGULAR STRENGTH 500

    Goes to Work in Seconds!

    Peppermint

    150 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

    Front Label: 103781XA

    Back Label: 103780XA

    Tums Regular Peppermint 150 count label
  • INGREDIENTS AND APPEARANCE
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0071
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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, green) Scoreno score
    ShapeROUNDSize16mm
    FlavorCHERRY (assorted fruit, orange, lemon, lime) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0071-27150 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2010
    2NDC:0135-0071-4812 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/10/2010
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0070-033 in 1 CELLO PACK03/10/2010
    112 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:0135-0070-27150 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2010
    3NDC:0135-0070-4812 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/10/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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