Label: ALKA-SELTZER ULTRA STRENGTH 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 March 19, 2019

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

    ● if pregnant do not take more than 5 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.

  • Directions

    Directions

    ● adults and children 12 years and over: fully chew then swallow 2 to 3 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

    ● if pregnant, do not take more than 5 chewable tablets in 24

    hours

  • OTHER SAFETY INFORMATION

    Other information

    each chewable tablet contains: calcium 400 mg

    ● store at room temperature. Avoid excessive heat above 40°C

    (104°F).

    ● close cap tightly after use

  • INACTIVE INGREDIENT

    Inactive ingredients acacia, carnauba wax, citric acid, corn syrup, dextrin, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake, FD&C Yellow #6, FD&C Yellow #6 aluminum lake, flavors, hydrogenated coconut oil, lecithin, maltodextrin, medium-chain triglycerides, methylparaben, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax

  • Questions or comments

    Questions or comments? 1-800-986-0369

    (Mon – Fri 9AM – 5PM EST)

  • 50 Tablet bottle label

    NEW!

    Delicious

    Creme

    Flavors

    Starts Neutralizing Acid

    in Seconds!

    Alka-Seltzer®

    Calcium Carbonate/Antacid

    ULTRA STRENGTH

    HEARTBURN

    RELIEFCHEWS®

    Strawberry &

    Orange Creme

    50 CHEWABLE TABELTS

    Bottle label 50 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS  STRAWBERRY AND ORANGE
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0059
    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
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ACACIA (UNII: 5C5403N26O)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SHELLAC (UNII: 46N107B71O)  
    SORBIC ACID (UNII: X045WJ989B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorred, orangeScoreno score
    ShapeROUNDSize19mm
    FlavorORANGE, STRAWBERRYImprint Code U2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0059-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/03/2019
    Labeler - Bayer HealthCare LLC. (112117283)