Label: ALKA-SELTZER KIDS TUMMY RELIEFCHEWS- calcium carbonate and dimethicone tablet, chewable

  • 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 February 1, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients and purpoose

    Active ingredients (in each chewable tablet) Purpose
    Calcium carbonate 750 mg….................................….…...Antacid
    Simethicone 80 mg……………………………………….......Antigas

  • PURPOSE

  • INDICATIONS & USAGE

    Uses for the relief of:
    ● acid indigestion ● heartburn ● sour stomach
    ● upset stomach associated with these symptoms
    ● bloating, pressure, or stuffed feeling commonly referred to as gas

  • 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
    ● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period
    ● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period
    ● if pregnant, do not take more than 6 chewable 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years and over• fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
    • do not take more than 6 chewable tablets in a 24-hour period
    children 6 years to under 12 years• under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.
    • do not take more than 4 chewable tablets in a 24-hour period
    children under 6 yearsconsult a doctor

    • if pregnant, do not take more than 6 chewable tablets in 24 hours

  • OTHER SAFETY INFORMATION

    Other information
    ● each chewable tablet contains: calcium 300 mg
    ● store at room temperature. Avoid excessive heat above 40°C (104°F).
    ● close cap tightly after use

  • INACTIVE INGREDIENT

    Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax

  • QUESTIONS

    Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • Package label 28 count

    Works

    Amazingly

    Fast!

    Alka-Seltzer® Kids

    Tummy ReliefChews®

    Calcium Carbonate/Antiacid

    Simethicone/Antigas

    •6 Symptom Relief•

    •Upset Stomach

    •Gas • Bloating

    •Acid Indigestion

    •Heartburn

    •Upset Stomach

    FRUIT PUNCH

    28 CHEWABLE TABLETS

    AS Tummy Relief Chewables

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER KIDS TUMMY RELIEFCHEWS 
    calcium carbonate and dimethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0051
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHELLAC (UNII: 46N107B71O)  
    ACACIA (UNII: 5C5403N26O)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize18mm
    FlavorFRUIT PUNCHImprint Code HG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0051-0128 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/01/2021
    Labeler - Bayer HealthCare LLC. (112117283)