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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 28, 2020

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

  • 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 not finalpart34304/11/2011
    Labeler - Bayer HealthCare LLC. (112117283)