Label: ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS- 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 October 16, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Calcium carbonate 1000 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

    ● 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

    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

    ● children under 12 years: consult a doctor

    ● do not take more than 5 chewable tablets in a 24-hour period

  • Other

    Other information

    each chewable tablet contains: calcium 400 mg

    ● store at room temperature. Avoid humidity.

    ● close cap tightly after use

  • INACTIVE INGREDIENT

    Inactive ingredients acacia, annatto extract, ascorbyl palmitate, beta carotene, carnauba wax, citric acid, confectioners sugar, corn syrup, disodium EDTA, dl-alpha-Tocopherol, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, methylparaben, modified starch, potassium hydroxide, potassium sorbate, propylene glycol, propylparaben, shellac, silicon dioxide, sodium ascorbate, sorbic acid, sorbitol, sugar, titanium dioxide, turmeric oleoresin, vegetable oil, water, white wax

  • QUESTIONS

    Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • Package label 50 count

    tropical twist

    Alka-Seltzer®

    Calcium Carbonate/Antacid

    ULTRA STRENGTH

    HEARTBURN

    RELIEFCHEWS®

    FAST POWERFUL RELIEF

    50 CHEWABLE TABLETS

    Label 50 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0245
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CORN OIL (UNII: 8470G57WFM)  
    PALM OIL (UNII: 5QUO05548Z)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TURMERIC (UNII: 856YO1Z64F)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    ACACIA (UNII: 5C5403N26O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    Product Characteristics
    Colororange, yellowScoreno score
    ShapeROUNDSize18mm
    FlavorTROPICAL FRUIT PUNCH, PEACH, MANGOImprint Code U2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0245-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/01/2017
    Labeler - Bayer HealthCare LLC. (112117283)