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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 7, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)