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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 9, 2012

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

  • Active Ingredients (in each tablet)

    Aspirin 325 mg

    Citric acid 1000 mg

    Sodium Bicarbonate (heat treated) 1916 mg

  • Purpose

    Analgesic, Antacid

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses for the 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 should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

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

    • hives
    • asthma (wheezing)

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

  • 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

  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
    or www.alkaseltzer.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALKA SELTZER 
    aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION1916 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code ALKA;SELTZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53666-403-15150 in 1 CASE
    1NDC:53666-403-3312 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/10/2012
    ALKA SELTZER 
    aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION1916 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code ALKA;SELTZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53666-100-10100 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/10/2012
    Labeler - Salimex, S.A. (589201581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer de Mexico, S.A. de CV588165709manufacture(53666-403)