Label: ALKA-SELTZER ORIGINAL FLAVOR- buffered aspirin, effervescent tablet tablet, effervescent

  • NDC Code(s): 66715-6403-2, 66715-6403-7, 66715-6403-8, 66715-6503-2, view more
    66715-9603-2, 66715-9603-3
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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

  • Drug Facts

  • Active ingredients

    Active ingredients (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

    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 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 a doctor before use if

    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

    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

    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

    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 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 8 tablets in 24 hours
    children under 12 yearsask 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 or comments

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

  • SPL UNCLASSIFIED SECTION

    Bayer

    Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981


    This product is repackaged 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. 97033C-US-03-22


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


    Made in Mexico

  • PDP/Package

    [Bayer cross]

    Alka-

    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain Reliever/fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    6

    Effervescent Tablets

    (3 - 2 count pouches)

    [Lil' Drug Store logo]

    PDP/Package

  • Alka-Seltzer Original, CVP HEALTH PDP/Package

    [Bayer cross]

    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 logo]

    PDP/Package

  • Alka-Seltzer Original, Travel BASIX PDP/Package

    Alka-

    Seltzer ®

    Buffered aspirin (NSAID) /

    Pain Reliever/fever reducer

    Fast Relief of:

    Headache

    Backache

    Body Aches

    Muscle Pain

    ORIGINAL FLAVOR

    [Bayer cross]

    4

    Effervescent Tablets

    (2 - 2 count pouches)

    [Lil' Drug Store logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER ORIGINAL FLAVOR 
    buffered aspirin, effervescent tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6503
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6503-22 in 1 CARTON05/06/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/06/2022
    ALKA-SELTZER ORIGINAL FLAVOR 
    buffered aspirin, effervescent tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9603
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9603-22 in 1 CARTON12/01/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9603-33 in 1 CARTON12/01/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/01/2022
    ALKA-SELTZER ORIGINAL FLAVOR 
    buffered aspirin, effervescent tablet tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6403
    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)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code Alka;Seltzer
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6403-22 in 1 CARTON11/28/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-6403-725 in 1 CARTON04/19/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-6403-830 in 1 CARTON04/19/2022
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/19/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)