Label: ALKA-SELTZER ORIGINAL FLAVOR tablet, effervescent

  • NDC Code(s): 0280-0087-02, 0280-0087-03, 0280-0087-04
  • Packager: Bayer HealthCare LLC.
  • 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 April 4, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Buffered aspirin 325 mg (NSAID)*

  • PURPOSE

    Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

  • INDICATIONS & USAGE

    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: 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



    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 DOCTOR

    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 DOCTOR/PHARMACIST

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

    ● diabetes ● gout ● arthritis

  • STOP USE

    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 last more than 10 days

    ● fever gets worse or last more than 3 days

    ● redness or swelling is present

    ● new symptoms occur

    ● ringing in the ears or a loss of hearing occurs

  • PREGNANCY 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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY 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 INGREDIENT

    Inactive Ingredients anhydrous citric acid, sodium bicarbonate

  • QUESTIONS

    Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer Original Flavor 24ct

    Alka-Seltzer

    Buffered Aspirin (NSAID) / Pain reliever / fever reducer

    Fast Relief of:
    Headache
    Backache
    Body Aches
    Muscle Pain

    ORIGINAL FLAVOR

    24 EFFERVESCENT TABLETS

    (12 - 2 count pouches)

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ORIGINAL FLAVOR 
    alka-seltzer original flavor tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0087
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 1000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) 1916 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0087-0412 in 1 CARTON03/03/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0087-0218 in 1 CARTON03/03/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-0087-0336 in 1 CARTON04/04/2022
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/03/2022
    Labeler - Bayer HealthCare LLC. (112117283)