Label: ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH (anhydrous citric acid, sodium bicarbonate- heat-treated tablet, effervescent

  • NDC Code(s): 0280-0079-01, 0280-0079-02
  • 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 May 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Anhydrous citric acid 1000 mg

    Sodium bicarbonate (heat-treated) 1976 mg

  • PURPOSE

    Antacid

    Antacid

  • INDICATIONS & USAGE

    Uses for the relief of

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

    Warnings

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

  • ASK DOCTOR

    Ask a doctor before use if you have a sodium-restricted diet

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

  • WHEN USING

    When using this product do not exceed recommended dosage

  • STOP USE

    Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

  • PREGNANCY 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ● fully dissolve 2 tablets in 4 ounces of water before taking

    adults and children 12 years and over2 tablets every 4 hours as needed, or as directed by a doctordo not exceed 8 tablets in 24 hours
    adults 60 years and over2 tablets every 4 hours as needed, or as directed by a doctordo not exceed 4 tablets in 24 hours
    children under 12 yearsconsult a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ● each tablet contains: sodium 586 mg
    ● store at room temperature. Avoid excessive heat.
    ● Alka-Seltzer Extra Strength in water contains the antacid
    sodium citrate as the principal active ingredient

  • INACTIVE INGREDIENT

    Inactive ingredients

    magnesium stearate, mannitol

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    ​ALKA-SELTZER

    Fast 4-in-1

    Relief of:

    Heartburn

    Sour Stomach

    Acid Indigestion

    Upset Stomach

    HEARTBURN RELIEF

    EXTRA STRENGTH

    24 EFFERVESCENT TABLETS

    (12 - 2 count pouches)

    AlkaSeltzerHRES

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH 
    anhydrous citric acid, sodium bicarbonate (heat-treated) tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0079
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1976 mg
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize25mm
    FlavorImprint Code ALKA;SELTZER;EX;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0079-0112 in 1 CARTON09/21/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0280-0079-0236 in 1 CARTON05/23/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/21/2021
    Labeler - Bayer Healthcare LLC (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer de Mexico, S.A. de C.V.588165709manufacture(0280-0079)
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