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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 15, 2021

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

  • 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 finalpart33103/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)