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

  • NDC Code(s): 0067-2039-02, 0067-2039-07, 0067-2039-08, 0067-2039-09, view more
    0067-2039-24, 0067-2039-30, 0067-2039-33, 0067-2039-50, 0067-2039-77, 0067-2039-83, 0067-2039-84, 0067-2039-86, 0067-2039-91, 0067-2039-92, 0067-2039-94
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 5, 2024

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  • Active ingredients (in each caplet)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID*)
    Caffeine 65 mg

    * nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Uses

    • 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 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

  • Principal Display Panel

    NDC 0067-2039-24

    See new warnings information

    EXCEDRIN ®

    MIGRAINE

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain Reliever/Pain Reliever Aid

    24

    CAPLETS*

    * CAPSULE-SHAPED TABLETS

    TAMPER-EVIDENT BOTTLE

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

    Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

    ©2017 GSK or its licensor.

    Visit us at www.excedrin.com

    62000000012933

    62000000012933_Excedrin Migraine Caplets_24 ct.JPG
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN   MIGRAINE
    acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2039
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    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
    Colorwhite (White) Scoreno score
    ShapeCAPSULE (Capsule shaped tablet) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2039-022 in 1 POUCH; Type 0: Not a Combination Product02/15/2010
    2NDC:0067-2039-081 in 1 CARTON02/15/201012/31/2014
    28 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2039-091 in 1 CARTON02/15/201007/31/2017
    310 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2039-241 in 1 CARTON02/15/2010
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2039-301 in 1 CARTON02/15/2010
    530 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2039-501 in 1 CARTON02/15/2010
    650 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0067-2039-94100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201012/31/2012
    8NDC:0067-2039-911 in 1 CARTON02/15/2010
    8100 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0067-2039-831 in 1 CARTON02/15/2010
    9125 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0067-2039-84125 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201007/31/2014
    11NDC:0067-2039-861 in 1 CARTON02/15/201012/31/2014
    11125 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0067-2039-921 in 1 CARTON02/15/2010
    12200 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:0067-2039-771 in 1 CARTON02/15/2010
    13250 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:0067-2039-07250 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201012/31/2012
    15NDC:0067-2039-331 in 1 CARTON02/15/2010
    15300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02080202/15/2010
    Labeler - Haleon US Holdings LLC (079944263)
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