Label: EXCEDRIN MIGRAINE- acetaminophen, aspirin, and caffeine tablet, film coated

  • NDC Code(s): 0067-2040-01, 0067-2040-02, 0067-2040-03, 0067-2040-04, view more
    0067-2040-05, 0067-2040-06, 0067-2040-07, 0067-2040-08, 0067-2040-09
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 14, 2024

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  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Use

    •
    treats migraine
  • 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: Acetaminophen may cause severe skin reactions. Symptoms may include:

    •
    skin reddening
    •
    blisters
    •
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

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

    •
    hives
    •
    facial swelling
    •
    asthma (wheezing)
    •
    shock

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 2 caplets in 24 hours, which is the maximum daily amount
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using this product

    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

    Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.

    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.

    Do not use

     
    •
    if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    •
    you have never had migraines diagnosed by a health professional
    •
    you have a headache that is different from your usual migraines
    •
    you have the worst headache of your life
    •
    you have fever and stiff neck
    •
    you have headaches beginning after or caused by head injury, exertion, coughing or bending
    •
    you experienced your first headache after the age of 50
    •
    you have daily headaches
    •
    you have a migraine so severe as to require bed rest
    •
    you have liver disease
    •
    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 problems or serious side effects from taking pain relievers or fever reducers
    •
    you have vomiting with your migraine headache

    Ask a doctor or pharmacist before use if you are

    •
    taking a prescription drug for:
    •
    diabetes
    •
    gout
    •
    arthritis
    •
    under a doctor’s care for any serious condition
    •
    taking any other drug
    •
    taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

    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
    •
    your migraine is not relieved or worsens after first dose
    •
    new or unexpected symptoms occur
    •
    ringing in the ears or loss of hearing occurs

    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.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not use more than directed
    •
    adults: take 2 caplets with a glass of water
    •
    if symptoms persist or worsen, ask your doctor
    •
    do not take more than 2 caplets in 24 hours, unless directed by a doctor
    •
    under 18 years of age: ask a doctor
  • Other information

    •
    store at controlled room temperature 20°-25°C (68°-77°F)
    •
    close cap tightly after use
    •
    read all product information before using. Keep this box for important information.
  • Inactive ingredients

    benzoic acid, carnauba wax, FD&C blue no. 1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

  • Questions?

    1-800-468-7746

  • Additional Information

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL INPRINTED WITH “SEALED for YOUR PROTECTION”

    IS BROKEN OR MISSING

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2020 GSK or licensor.

    Trademarks are owned by or licensed to the GSK group of companies.

  • Principal Display Panel

    NDC 0067-2040-04

    EXCEDRIN

    MIGRAINE

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain Reliever/Pain Reliever Aid

    50 CAPLETS

    *CAPSULE-SHAPED TABLETS

    6414070 Front Carton

    Excedrin Migraine Caplet 2040
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  MIGRAINE
    acetaminophen, aspirin, and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (Capsule-Shaped Tablet) Size16mm
    FlavorImprint Code E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2040-021 in 1 CARTON09/30/2020
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-2040-031 in 1 CARTON09/30/2020
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2040-041 in 1 CARTON09/30/2020
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2040-051 in 1 CARTON09/30/2020
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2040-061 in 1 CARTON09/30/2020
    5125 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2040-071 in 1 CARTON09/30/2020
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0067-2040-081 in 1 CARTON09/30/2020
    7250 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0067-2040-091 in 1 CARTON09/30/2020
    8300 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0067-2040-012 in 1 POUCH; Type 0: Not a Combination Product01/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02080209/30/2020
    Labeler - Haleon US Holdings LLC (079944263)
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