Label: ALKA-SELTZER HEARTBURN AND PAIN- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent

  • NDC Code(s): 0280-0160-01, 0280-0160-02, 0280-0160-03, 0280-0160-04, view more
    0280-0160-05
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    *
    nonsteroidal anti-inflammatory drug
    Anhydrous citric acid 1000 mgAntacid
    Aspirin 325 mg (NSAID) *Analgesic
    Sodium bicarbonate (heat-treated) 1916 mgAntacid
  • Uses

    • For the temporary relief of minor aches and pains with heartburn, sour stomach, or acid indigestion and upset stomach associated with these symptoms
    • for temporary relief of headaches, body aches, backache and pain alone
  • Warnings

    Reye's syndrome

    Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma
    • 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.
    • taking a prescription drug for diabetes, gout, or arthritis

    When using this product do not take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • pain get worse or last more than 10 days
    • redness or swelling is present
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    ● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking

    ● Do not exceed recommended dose. SEE WARNINGS

    adults and children 12 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24 hours
    adults 60 years and over2 tablets every 4 hours, 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 568 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer Heartburn + Pain in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
  • Inactive ingredients

    none

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by: Bayer HealthCare LLC

    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

    PDP

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HEARTBURN AND PAIN 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code ASP;SAC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0160-0158 in 1 CARTON02/03/2025
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0160-026 in 1 CARTON02/03/2025
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-0160-0312 in 1 CARTON02/03/2025
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0280-0160-0418 in 1 CARTON02/03/2025
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-0160-0536 in 1 CARTON02/03/2025
    52 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/03/2025
    Labeler - Bayer HealthCare LLC. (112117283)