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
  • 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 March 21, 2019

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

  • 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
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    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)  
    SORBIC ACID (UNII: X045WJ989B)  
    XYLITOL (UNII: VCQ006KQ1E)  
    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 finalpart33103/03/2019
    Labeler - Bayer HealthCare LLC. (112117283)