Label: ALKA-SELTZER COOL ACTION HEARTBURN RELIEF MINT- calcium carbonate gum, chewing

  • NDC Code(s): 0280-0001-01, 0280-0001-02, 0280-0001-03
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewing piece)

    Calcium carbonate 750 mg

  • PURPOSE

    Purpose

    Antacid

  • Uses

    Uses for the relief of:

    ● acid indigestion ● heartburn ● sour stomach

    ● upset stomach associated with these symptoms

  • WARNINGS

    Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

    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 use more than 5 pieces in a 24-hour period

    ● if pregnant do not use more than 5 pieces in a 24-hour period

    ● do not use the maximum dosage of this product for more

    than 2 weeks except under the advice and supervision of a

    physician

    If pregnant or breast-feeding, inform your doctor that you are using this product.

    Keep out of reach of children.

  • Directions

    Directions

    ● adults and children 12 years and over: chew 1 - 2 pieces as symptoms occur or as directed by a doctor

    ● children under 12 years: consult a doctor

    ● do not use more than 5 pieces in a 24-hour period

    ● if pregnant, do not use more than 5 pieces in 24-hour period

    ● do not swallow the gum

  • OTHER SAFETY INFORMATION

    Other information

    ● each piece contains: calcium 300 mg

    ● store at room temperature. Avoid humidity and excessive heat above 40ºC (104ºF).

  • INACTIVE INGREDIENT

    Inactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-800-986-0369

    (Mon – Fri 9AM – 5PM EST)

  • Carton count 16 pieces

    Works Fast!

    Alka-Seltzer®

    Calcium Carbonate/

    Antacid

    EXTRA STRENGTH

    COOL ACTION

    HEARTBURN RELIEF

    GUM

    cool mint

    16 pieces

    16 count carton

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER COOL ACTION HEARTBURN RELIEF  MINT
    calcium carbonate gum, chewing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOMALT (UNII: S870P55O2W)  
    SORBITOL (UNII: 506T60A25R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorblue (Blue and white; Active on white) Scoreno score
    ShapeROUNDSize16mm
    FlavorMINTImprint Code 750
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0001-012 in 1 CARTON03/01/2020
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0280-0001-021 in 1 CARTON05/01/2020
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0280-0001-031 in 1 POUCH; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)
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