Label: ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT- calcium carbonate tablet, chewable

  • NDC Code(s): 0280-0058-30, 0280-0058-50
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • SPL INDEXING DATA ELEMENTS SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    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 take more than 5 chewable tablets in a 24-hour
    period

    ● if pregnant do not take more than 5 tablets in 24 hours

    ● 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: fully chew then swallow 2 to 4 chewable tablets as symptoms occur, or as directed by a doctor

    ● children under 12 years: consult a doctor

    ● do not take more than 5 chewable tablets in a 24-hour period

    ● if pregnant, do not take more than 5 chewable tablets in 24

    hours

  • Other information

    Other information

    ● each chewable tablet contains: calcium 300 mg

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

    ● avoid excessive humidity

    ● close cap tightly after use

  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, citric acid, coconut oil, corn syrup, dextrin, FD&C Blue No.1, FD&C Blue No.1 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, flavors, glycerin, gum arabic, lecithin, maltodextrin, mono and diglycerides, potassium sorbate, propylene glycol, purified water, shellac, sorbic acid, sucrose, titanium dioxide, vegetable oil, white wax, xylitol

  • Questions or comments

    Questions or comments? 1-800-986-0369

    (Mon – Fri 9AM – 5PM EST)

  • Bottle label 30 tablets

    Starts Neutralizing Acid

    in Seconds!

    NEW

    Cooling

    Sensation

    Alka-Seltzer®

    Calcium Carbonate/Antacid

    EXTRA STRENGTH

    COOL ACTION

    HEARTBURN

    RELIEFCHEWS®

    cool mint

    30 Chewable Tablets

    AS Cool Action Relief Chews Mint bottle label

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0058
    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
    CORN SYRUP (UNII: 9G5L16BK6N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCROSE (UNII: C151H8M554)  
    SORBIC ACID (UNII: X045WJ989B)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize18mm
    FlavorMINTImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0058-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/2019
    2NDC:0280-0058-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/03/2019
    Labeler - Bayer HealthCare LLC. (112117283)
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