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 06/13

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

    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
    do not use the maximum dosage for more than 2 weeks

    Keep Out of Reach of Children.

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  • Directions

    take 2-4 tablets as symptoms occur, or as directed 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 (Peppermint)

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

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  • Inactive ingredients (Spearmint)

    calcium stearate, corn starch, FD&C Blue #1, FD&C Yellow #5 (tartrazine), gum acacia, maltodextrin, natural & artificial flavor, 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 RICH

    25 CHEWABLE TABLETS

    PAREVE

    CHEW OR SAVOR

    ACTUAL SIZE

    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.

    Goes to Work in Seconds!

    Fast Heartburn Relief, Fresh Breath

    Keep this outer packaging for complete labeling information.

    If using this product as a calcium supplement, do not exceed 5 tablets per day without consulting a doctor.

    www.tums.com

    Gluten-Free

    TUMS® and TUMS logo design are registered trademarks and FRESHERS and the ice cube design are trademarks of the GlaxoSmithKline group of companies.

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2011 GlaxoSmithKline

    101214PB

    TUMS Freshers antacid cool mint 25 count chewable tablets carton
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  • Principal Display Panel

    NDC 0135-0541-02

    TUMS®

    freshers®

    ANTACID

    Fast Relief, Fresh Breath

    spearmint

    CALCIUM RICH

    25 CHEWABLE TABLETS

    3879

    Fast Heartburn Relief, Fresh Breath.

    Goes to Work in Seconds!

    Contains natural mint oils to help freshen breath.

    Gluten-Free

    If using this product as a calcium supplement, do not exceed 5 tablets per day without consulting a doctor.

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

    GlaxoSmithKline Consumer Healthcare, L.P

    Moon Township, PA 15108

    www.tums.com

    TUMS®, FRESHERS®, the ice cube device and other marks are trademarks of the GlaxoSmithKline group of companies.

    ©2013 GlaxoSmithKline

    Front of 25 ct label: 102406XA

    Back of 25 ct. label: 102407XA

    2x25 ct card: 102402PB

    Tums Freshers spearmint 25 ct tablets label
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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
    2 NDC:0135-0522-02 1 in 1 CARTON
    2 25 in 1 BOTTLE
    3 NDC:0135-0522-03 2 in 1 CARTON
    3 25 in 1 BOTTLE
    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 BLUE NO. 1  
    FD&C YELLOW NO. 5  
    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
    2 NDC:0135-0541-03 2 in 1 CARTON
    2 NDC:0135-0541-02 25 in 1 BOTTLE
    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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