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

  • 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 December 6, 2019

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  • Drug Facts

  • Active ingredients (in each tablet)

    Anhydrous citric acid 1000 mg

    Sodium bicarbonate (heat-treated) 1940 mg

  • Purpose

    Active ingredients (in each tablet)...................................................................................Purpose
    Anhydrous citric acid 1000 mg....................................................................................... Antacid
    Sodium bicarbonate (heat-treated) 1940 mg ..............................................................Antacid

  • Uses

    for the relief of

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

    Do not use

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

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    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

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor

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

  • 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

    Keep out of reach of children.

  • 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 information

    • each tablet contains: sodium 575 mg
    • phenylketonurics: contains phenylalanine 5.6 mg per tablet
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer Heartburn in water contains the antacid sodium citrate as the principal
      active ingredient
  • Inactive ingredients

    acesulfame potassium, aspartame, flavors, magnesium stearate, mannitol

  • Questions or comments?

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

  • Alka-Seltzer Heartburn Effervescent Tablets

    36ct

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN 
    anhydrous citric acid, sodium bicarbonate (heat-treated) tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0047
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1940 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code ALKA;SELTZER;HR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0047-3618 in 1 CARTON03/02/2010
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/02/2010
    Labeler - Bayer HealthCare LLC. (112117283)