Label: ALKA-SELTZER ORIGINAL- anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent

  • NDC Code(s): 0280-4000-01, 0280-4000-02, 0280-4000-03, 0280-4000-04, view more
    0280-4000-05, 0280-4000-06, 0280-4000-07
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 4, 2023

If you are a healthcare professional or from the pharmaceutical industry 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:

    • 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 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

    Directions

    ● fully dissolve 2 tablets in 4 ounces of water before taking

    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 567 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer 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

    Alka-

    Seltzer ®

    Anhydrous citric acid / Antacid

    Aspirin ( NSAID) / Analgesic

    Sodium bicarbonate / Antacid

    Fast Relief of:

    Heartburn

    Upset Stomach

    Acid Indigestion

    with Headache

    Body Aches

    ORIGINAL

    24 EFFERVESCENT TABLETS

    original

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ORIGINAL 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-4000
    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 ALKA;SELTZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-4000-016 in 1 CARTON10/10/2012
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-4000-0224 in 1 CARTON10/10/2012
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-4000-0318 in 1 CARTON10/10/2012
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0280-4000-0726 in 1 CARTON10/10/2012
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-4000-0458 in 1 CARTON10/10/2012
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0280-4000-0536 in 1 CARTON10/10/2012
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:0280-4000-0612 in 1 CARTON03/24/2022
    72 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/02/2010
    Labeler - Bayer HealthCare LLC. (112117283)