Label: ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE- calcium carbonate 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 July 30, 2020

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

  • SPL UNCLASSIFIED SECTION

    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 10 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 10 chewable tablets in a 24-hour period
  • Other information

    • each chewable tablet contains: calcium 300 mg
    • store at room temperature. Avoid excessive heat above 40°C (104°F).
  • Inactive ingredients

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

  • Questions or comments?

    1-800-986-0369
    (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

  • SPL UNCLASSIFIED SECTION

    Dist. by: Bayer HealthCare LLC
    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton

    ON-THE-GO PACK

    PEEL

    strawberry & orange

    Alka-

    Seltzer ®

    Calcium Carbonate /Antacid

    EXTRA STRENGTH

    HEARTBURN

    RELIEFCHEWS ™

    6 CHEWABLE

    TABLETS

    Label 6

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0224
    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
    ACACIA (UNII: 5C5403N26O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    Colorpink, orangeScoreno score
    ShapeROUNDSize18mm
    FlavorSTRAWBERRY, ORANGEImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0224-061 in 1 CARTON03/15/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/15/2014
    Labeler - Bayer HealthCare LLC. (112117283)