Label: TUMS FRESHERS- calcium carbonate tablet, chewable

  • NDC Code(s): 0135-0522-01, 0135-0522-02, 0135-0522-03, 0135-0541-01, view more
    0135-0541-02, 0135-0541-03
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/14

If you are a consumer or patient please visit this version.

  • Active ingredient (per tablet)

    Calcium carbonate USP 500mg

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  • Purpose

    Antacid

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  • Uses

    relieves

    heartburn
    sour stomach
    acid indigestion
    upset stomach associated with these symptoms
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  • 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 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.

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  • 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
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  • Other information

    each tablet contains: elemental calcium 200mg
    store below 25°C (77°F)
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  • Inactive ingredients (Cool Mint)

    calcium stearate, corn starch, FD&C Blue #1, flavors, gum acacia, maltodextrin, sorbitol, sucralose, sucrose, tocopherols

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  • Inactive ingredients (Spearmint)

    calcium stearate, corn starch, FD&C Yellow #5 (tartrazine), FD&C Blue #1, flavors, gum acacia, maltodextrin, sorbitol, sucralose, sucrose, tocopherols

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  • Questions or Comments?

    1-800-897-7535 (English/Spanish) weekdays

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  • Principal Display Panel

    NDC 0135-0522-02

    TUMS®

    freshers®

    ANTACID

    Fast Relief, Fresh Breath

    Cool Mint

    CALCIUM CARBONATE

    FAST ANTACID

    COOLING TABS

    25 CHEWABLE TABLETS

    PAREVE

    See Inside for Valuable Coupon!

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

    Contains natural mint oils to help freshen breath.

    Keep this outer packaging for complete labeling information.

    www.tums.com

    Gluten-Free

    TUMS, FRESHERS and the logo device are registered trademarks of the GSK group of companies.

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2014 GlaxoSmithKline

    103559PA

    Tums Freshers Cool Mint 25 count carton
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  • Principal Display Panel

    NDC 0135-0541-03

    TUMS

    freshers®

    ANTACID

    CALCIUM CARBONATE

    Spearmint

    FAST ANTACID

    COOLING TABS

    TWIN PACK 2X25 CHEWABLE TABLETS

    PAREVE

    TUMS, FRESHERS and the logo device are registered trademarks of the GSK group of companies.

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

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2014 GSK

    Blistercard: 103564PA

    Inlay Card: 103565PA

    Tums Freshers Spearmint Twin Pack blistercard
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  • INGREDIENTS AND APPEARANCE
    TUMS  FRESHERS
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0522
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE  
    STARCH, CORN  
    FD&C BLUE NO. 1  
    ACACIA  
    MALTODEXTRIN  
    SORBITOL  
    SUCRALOSE  
    SUCROSE  
    TOCOPHEROL  
    Product Characteristics
    Color WHITE (with blue speckles) Score no score
    Shape OVAL Size 13mm
    Flavor PEPPERMINT (cool mint) Imprint Code TUMS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0522-01 2 in 1 POUCH; Combination Product Type = C112160 02/02/2012
    2 NDC:0135-0522-02 1 in 1 CARTON 02/02/2012
    2 25 in 1 BOTTLE; Combination Product Type = C112160
    3 NDC:0135-0522-03 2 in 1 PACKAGE 02/02/2012
    3 25 in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 02/02/2012
    TUMS  FRESHERS
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0541
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE  
    STARCH, CORN  
    FD&C YELLOW NO. 5  
    FD&C BLUE NO. 1  
    ACACIA  
    MALTODEXTRIN  
    SORBITOL  
    SUCRALOSE  
    SUCROSE  
    TOCOPHEROL  
    Product Characteristics
    Color WHITE (with green speckles) Score no score
    Shape OVAL Size 13mm
    Flavor SPEARMINT Imprint Code TUMS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0541-01 2 in 1 POUCH; Combination Product Type = C112160 08/01/2013
    2 NDC:0135-0541-03 2 in 1 PACKAGE 08/01/2013
    2 NDC:0135-0541-02 25 in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 08/01/2013
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
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