Label: ALKA-SELTZER HEARTBURN PLUS GAS RELIEFCHEWS TROPICAL PUNCH- calcium carbonate and simethicone tablet, chewable

  • NDC Code(s): 0280-0225-01, 0280-0225-02, 0280-0225-03, 0280-0225-32, view more
    0280-0225-54, 0280-0225-82
  • 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 January 29, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)Purpose
    Calcium carbonate 750 mgAntacid
    Simethicone 80 mgAntigas
  • 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

    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 6 chewable tablets 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
    • constipation may occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
    • children under 12 years: consult a doctor
    • do not take more than 6 chewable tablets in a 24-hour period
  • Other information

    • each chewable tablet contains: calcium 330 mg
    • store at room temperature. Avoid excessive heat above 40°C (104°F).
    • close cap tightly after use
  • Inactive ingredients

    acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red #40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methyl paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, water, white wax

  • Questions?

    1-800-986-0369

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Bayer HealthCare LLC
    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Label

    Alka-

    Seltzer
    ®

    Calcium Carbonate / Antacid

    Simethicone / AntiGas

    tropical punch

    HEARTBURN+GAS

    RELIEFCHEW™

    Fast Powerful Relief

    BAYER

    32 CHEWABLE TABLETS

    ashbgsrc

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN PLUS GAS RELIEFCHEWS TROPICAL PUNCH 
    calcium carbonate and simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize18mm
    FlavorTROPICAL FRUIT PUNCHImprint Code HG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0225-3232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2014
    2NDC:0280-0225-5454 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2014
    3NDC:0280-0225-8282 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    4NDC:0280-0225-01110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
    5NDC:0280-0225-0228 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2014
    6NDC:0280-0225-0360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/15/2014
    Labeler - Bayer HealthCare LLC. (112117283)