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

  • NDC Code(s): 0280-0084-01, 0280-0084-02, 0280-0084-03, 0280-0084-04, view more
    0280-0084-05
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)
    Aspirin 500 mg (NSAID)*
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

    Pain reliever
    Alertness aid/pain reliever aid

  • Uses

    Uses

    • for the temporary relief of minor aches and pains associated with a hangover
    • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
    • for temporary relief of headaches, body aches, and pain alone

  • 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
    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of
    coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
    product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
    occasionally, rapid heart beat.
    ● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
    doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
    continues to recur, consult a doctor.

    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

    Caffeine warning

    The recommended dose of this product contains about as much caffeine as a cup of
    coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
    product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
    occasionally, rapid heart beat.
    ● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
    doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
    continues to recur, consult a doctor.

    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

    • 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 if you are

    taking a prescription drug for
    ● diabetes ● gout ● arthritis

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

  • Directions

    Directions

    ● fully dissolve 2 tablets in 4 ounces of water before taking

    Adults 18 years and over2 tablets every 6 hours as needed, or as directed by a doctordo not exceed 8 tablets in 24 hours
    Adults 60 years and over2 tablets every 6 hours as needed, or as directed by a doctordo not exceed 5 tablets in 24 hours
    Children under 18 yearsconsult a doctor

  • Other information

    ● each tablet contains: potassium 115 mg
    ● each tablet contains: sodium 371 mg
    Phenylketonurics: Contains Phenylalanine 5.4 mg per tablet
    ● store at room temperature. Avoid excessive heat

  • Inactive ingredients

    anhydrous citric acid, aspartame, dimethicone, docusate sodium, FD&C red No. 40, FD&C yellow No. 6, flavor, mannitol, potassium
    bicarbonate, povidone, sodium benzoate, sodium bicarbonate, sucralose

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by: Bayer HealthCare LLC

    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 20 Tablet Carton

    88056531_ALKA-SELTZER_Hangover_Relief_Orange_Tablet_20ct_Ctn_r3.jpgAlka-Seltzer ®

    HANGOVER RELIEF

    orange fizz

    FAST RELIEF OF
    headache, body aches
    mental fatigue

    20EFFERVESCENT TABLETS
    10 - 2 count pouches

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER HANGOVER RELIEF 
    anhydrous citric acid, aspirin, and sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code A;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0084-0110 in 1 CARTON02/21/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0280-0084-0218 in 1 CARTON04/19/2023
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0280-0084-0360 in 1 CARTON04/19/2023
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:0280-0084-042 in 1 CARTON04/19/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-0084-051600 in 1 BOX05/23/2023
    52 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/21/2022
    Labeler - Bayer HealthCare LLC. (112117283)