Label: ALKA-SELTZER EXTRA STRENGTH HEARTBURN RELIEFCHEWS- calcium carbonate tablet, chewable

  • NDC Code(s): 0280-0042-08, 0280-0042-36, 0280-0042-60, 0280-0042-90
  • 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 October 17, 2022

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  • Drug Facts

  • Active ingredient (in each chewable tablet)

    Calcium carbonate 750 mg

  • Purpose

    Antacid

  • Uses

    for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • 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
    • 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

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

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by as doctor
    • children under 12 years: consult a doctor
    • do not take more than 5 chewable tablets in a 24-hour period
  • Other information

    • each chewable tablet contains: calcium 300 mg
    • contains FD&C Yellow No. 5 (tartrazine) as a color additive
    • store at room temperature. Avoid humidity.
    • close cap tightly after use
  • Inactive ingredients

    acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

  • Questions or comments?

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

  • Principle display panel

    assorted fruit

    Alka-Seltzer

    Calcium Carbonate / Antacid

    Extra Strength

    Heartburn ReliefChews

    Fast

    Powerful

    relief

    Bayer

    60 CHEWABLE TABLETS

    ASESHBRC

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER EXTRA STRENGTH HEARTBURN RELIEFCHEWS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    SORBITOL (UNII: 506T60A25R)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    Colororange, yellow, pinkScoreno score
    ShapeROUNDSize25mm
    FlavorLEMON, STRAWBERRY, ORANGEImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0042-088 in 1 POUCH; Type 0: Not a Combination Product09/15/2016
    2NDC:0280-0042-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2016
    3NDC:0280-0042-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2016
    4NDC:0280-0042-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/15/2016
    Labeler - Bayer HealthCare LLC. (112117283)
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