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

  • 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 2, 2021

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

  • 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


  • 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

  • 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


  • Active ingredients (in each tablet)

    Citric acid
    Aspirin (NSAID)*
    Sodium bicarbonate (heat-treated)
    *nonsteroidal anti-inflammatory drug

    Purpose


    Citric acid 1000 mg...............................….……Antacid
    Aspirin 325 mg (NSAID)*…..………………….…………..Analgesic
    Sodium bicarbonate (heat-treated) 1916 mg.……………...Antacid
    *nonsteroidal anti-inflammatory drug

  • 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
  • Ask a doctor or pharmacist before use if you are

    ● presently taking a prescription drug.

    Antacids mayinteract 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

  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM –5PM EST)

  • 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

    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 doctor

    do not exceed 8

    tablets in 24 hours

    adults 60 years

    and over

    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

    ● 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

  • Front and Back

    Alka Seltzer

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER  ORIGINAL
    aspirin, citric acid, sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-218
    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) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code ALKA;SELTZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53666-218-14150 in 1 BOX10/03/2017
    1NDC:53666-218-136 in 1 BOX
    1NDC:53666-218-122 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/03/2017
    Labeler - SALIMEX, S.A. (589201581)
    Registrant - SALIMEX, S.A. (589201581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer de México, S.A. de C.V. 588165709manufacture(53666-218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Salimex, S.A.589201581relabel(53666-218)