Label: ALKA-SELTZER EXTRA STRENGTH- anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Anhydrous citric acid 1000 mgAntacid
    Aspirin 500 mgAnalgesic
    Sodium bicarbonate (heat-treated) 1985 mgAntacid
  • Uses

    for the temporary relief of:

    • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
    • upset stomach with headache from overindulgence in food or drink
    • headache, body aches, 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

    Do not use

    • if you are allergic to aspirin or 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 anticoagulation (blood thinning), diabetes, gout, or arthritis

    When using this product do not exceed recommended dosage

    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

    • symptoms get worse or last more than 10 days
    • redness or swelling is present
    • ringing in the ears or a loss of hearing occurs
    • new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • fully dissolve 2 tablets in 4 ounces of water before taking
    adults and children 12 years and over2 tablets every 6 hours, or as directed by a doctordo not exceed 7 tablets in 24 hours
    adults 60 years and over2 tablets every 6 hours, or as directed by a doctordo not exceed 3 tablets in 24 hours
    children under 12 yearsconsult a doctor
  • Other information

    • each tablet contains: sodium 588 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer Extra Strength in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
  • Inactive ingredients

    flavor

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 24 Tablets Carton

    Alka-

    Seltzer     ®

    ANTACID & PAIN RELIEF MEDICINE

    FAST

    RELIEF

    OF:

    Acid Indigestion

    Upset Stomach

    Heartburn with

    Headache

    Body Aches

    XTRA

    STRENGTH

    24 EFFERVESCENT TABLETS

    ASES24

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER EXTRA STRENGTH 
    anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0211
    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
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE1985 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON (UNII: 24RS0A988O)  
    Product Characteristics
    Colorwhite (White tablet) Scoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code ALKA;SELTZER;EX;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0211-2412 in 1 CARTON04/18/2011
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00104/11/2011
    Labeler - Bayer HealthCare LLC. (112117283)
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