Label: ALKA-SELTZER HEARTBURN- anhydrous citric acid and sodium bicarbonate granule, effervescent 

  • Label RSS
  • NDC Code(s): 0280-4085-36
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

    for the relief of

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

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

    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 exceed recommended dosage

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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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  • Directions

    • fully dissolve 2 tablets in 4 ounces of water before taking
    adults and children 12 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours
    adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours
    children under 12 years consult a doctor

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  • 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
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  • Inactive ingredients

    acesulfame potassium, aspartame, flavors, magnesium stearate, mannitol

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  • Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL - 36 Tablets Carton

    Alka-
    Seltzer
    ®

    ANTACID MEDICINE

    FAST, COOLING RELIEF OF:

    &Heartburn
    Acid Indigestion

    LEMON
    LIME

    HEARTBURN

    36 EFFERVESCENT
    TABLETS

    PRINCIPAL DISPLAY PANEL - 36 Tablets Carton
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  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN 
    anhydrous citric acid and sodium bicarbonate granule, effervescent
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-4085
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Anhydrous Citric Acid (Anhydrous Citric Acid) Anhydrous Citric Acid 1000 mg
    Sodium Bicarbonate (Sodium Cation) Sodium Bicarbonate 1940 mg
    Product Characteristics
    Color WHITE Score     
    Shape ROUND Size
    Flavor Imprint Code ALKA;SELTZER;HR
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-4085-36 36 in 1 CARTON
    1 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/02/2010
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
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