Label: ALKA-SELTZER- buffered aspirin tablet, effervescent

  • NDC Code(s): 66715-5206-0
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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

  • Pouch Header/PDP

    Do not use if pouch is torn or open.

    Alka-Seltzer ®

    Buffered aspirin (NSAID)/Pain reliever/fever reducer

    ORIGINAL FLAVOR

    [Bayer logo]

    Fast Relief

    2 EFFERVESCENT TABLETS

  • Active ingredient

    Active ingredient (in each tablet)

    Buffered aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Purpose

    Pain reliever/fever reducer

  • Uses

    Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscle pain
    • backache
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
    • temporarily reduces fever
  • Warnings

    ​Warnings

    Reye's syndrome

    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

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

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

    Stomach bleeding warning

    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 directedStomach bleeding warning: This product contains an NSAID, which

    Do not use

    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

    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

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor

    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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

    If pregnant or breast-feeding

    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

    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 over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 4 tablets in 24 hours. Children under 12 years: consult a doctor.

  • Other information

    Other information

    • each tablet contains: sodium 568 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate
  • Inactive ingredients

    Inactive ingredients anhydrous citric acid, sodium bicarbonate

  • Questions?

    Questions? 1-800-986-0369 Dist. By Bayer Healthcare LLC, Whippany, NJ 07981

  • Alka-Seltzer® Gravity Sleeve (unit dose) - PDP/Label

    [Bayer logo]

    Alka-

    Seltzer ®

    Buffered aspirin (NSAID)/

    Pain reliever/fever reducer

    ORIGINAL FLAVOR

    15 PACKETS OF

    2 EFFERVESCENT TABLETS

    [UPC]

    PouchPDP

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER 
    buffered aspirin tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorCITRUSImprint Code ALKA;SELTZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5206-015 in 1 BOX, UNIT-DOSE06/01/2023
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/01/2023
    Labeler - Lil' Drug Store Products, Inc. (093103646)