Label: EXCEDRIN MIGRAINE RELIEF (acetaminophen, aspirin- nsaid, caffeine tablet, film coated

  • NDC Code(s): 0067-2042-01, 0067-2042-02, 0067-2042-03, 0067-2042-04, view more
    0067-2042-05, 0067-2042-06, 0067-2042-07, 0067-2042-08
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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

  • Active ingredients (in each caplet)

    Acetaminophen 250mg

    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 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 or comments?

    1-800-468-7746

  • Principal Display Panel

    EXCEDRIN

    MIGRAINE RELIEF

    Acetaminophen 250 mg,Aspirin 250 mg (NSAID)
    and Caffeine 65 mg
    Pain Reliever / Pain Reliever Aid

    ACTUAL SIZE

    24
    CAPLETS*

    * CAPSULE-SHAPED TABLETS

    Distributed by: Haleon, Warren, NJ 07059

    ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000202358

    TAMPER-EVIDENT BOTTLE
    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH
    “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Excedrin migraine Relief 24 ct

  • INGREDIENTS AND APPEARANCE
    EXCEDRIN   MIGRAINE RELIEF
    acetaminophen, aspirin (nsaid), caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2042
    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)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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:0067-2042-011 in 1 CARTON01/01/2024
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-2042-021 in 1 CARTON01/01/2024
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2042-031 in 1 CARTON01/01/2024
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2042-041 in 1 CARTON01/01/2024
    4100 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2042-051 in 1 CARTON01/01/2024
    5125 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2042-061 in 1 CARTON01/01/2024
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0067-2042-071 in 1 CARTON01/01/2024
    7250 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0067-2042-08300 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/01/2024
    Labeler - Haleon US Holdings LLC (079944263)