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

  • NDC Code(s): 29485-6503-3, 29485-7535-2, 29485-7535-3
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredients

    Anhydrous citric acid 1000 mg
    Aspirin 325 mg (NSAID) * 1

    Sodium bicarbonate (heat-treated) 1916 mg


    1
    nonsteroidal anti-inflammatory drug
  • Purpose

    Antacid

    Analgesic

    Antacid

  • 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 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 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 over

    2 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

    Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981

    This product is packaged by Lil' Drug Store Products, Inc.,
    9300 Earhart Lane SW, Cedar Rapids, IA 52404
    1-877-507-6516 (M-F 8AM-4:30PM CST),

    from a product manufactured by Bayer.

    “Bayer, the Bayer Cross and Alka-Seltzer are registered
    trademarks of Bayer, used with permission.” Product of Mexico

  • 25 Count Box

    Alka-
    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain reliever / fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    50 Effervescent Tablets
    (25 - 2 count pouches)

    Alka-
    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain reliever / fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    50 Effervescent Tablets
    (25 - 2 count pouches)

    Alka Seltzer 25 count box

  • 30 Count Box

    Alka-
    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain reliever / fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    60 Effervescent Tablets
    (30 - 2 count pouches)

    Alka Seltzer 30 count box

  • CVP 4 Count Carton

    Alka-
    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain reliever / fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    4

    Effervescent Tablets
    (2 - 2 count pouches)

    CVP

    HEALTH

    Alka Seltzer CVP 4ct

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ORIGINAL 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6503
    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:29485-6503-330 in 1 CARTON05/16/201912/31/2025
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/16/201912/31/2025
    ALKA-SELTZER ORIGINAL 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7535
    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:29485-7535-225 in 1 BOX07/10/202012/31/2025
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:29485-7535-330 in 1 BOX11/17/201612/31/2025
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/17/201612/31/2025
    Labeler - Lil' Drug Store Products, Inc. (093103646)