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

  • NDC Code(s): 67414-239-02
  • Packager: Jones Healthcare Group - Packaging Services, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2024

If you are a consumer or patient 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

    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. Reye’s syndrome:

    Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

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

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

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

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding 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. Caffeine warning

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • 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
    • 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

    • 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 during the last 3 months of 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 #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

  • Questions or comments?

    1-800-468-7746

  • Package Labeling

    ExcedrinMigraine

  • INGREDIENTS AND APPEARANCE
    EXCEDRIN   MIGRAINE
    acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67414-239
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeCAPSULE (Capsule shaped tablet) Size18mm
    FlavorImprint Code E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67414-239-022000 in 1 BOX01/24/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/24/2018
    Labeler - Jones Healthcare Group - Packaging Services, Inc (243261024)
    Registrant - Jones Healthcare Group - Packaging Services, Inc (243261024)