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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 1, 2018

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

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  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

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  • Uses

    treats migraine
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  • 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.

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  • 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
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  • 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.
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  • 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

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  • Questions or comments?

    1-800-468-7746

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  • 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
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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  MIGRAINE
    acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2039
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (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
    Color WHITE (White) Score no score
    Shape CAPSULE (Capsule shaped tablet) Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2039-02 2 in 1 POUCH; Type 0: Not a Combination Product 02/15/2010
    2 NDC:0067-2039-08 1 in 1 CARTON 02/15/2010
    2 8 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0067-2039-09 1 in 1 CARTON 02/15/2010
    3 10 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0067-2039-24 1 in 1 CARTON 02/15/2010
    4 24 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0067-2039-30 1 in 1 CARTON 02/15/2010
    5 30 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0067-2039-50 1 in 1 CARTON 02/15/2010
    6 50 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0067-2039-94 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2010 12/31/2012
    8 NDC:0067-2039-91 1 in 1 CARTON 02/15/2010
    8 100 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:0067-2039-83 1 in 1 CARTON 02/15/2010
    9 125 in 1 BOTTLE; Type 0: Not a Combination Product
    10 NDC:0067-2039-84 125 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2010 07/31/2014
    11 NDC:0067-2039-86 1 in 1 CARTON 02/15/2010
    11 125 in 1 BOTTLE; Type 0: Not a Combination Product
    12 NDC:0067-2039-92 1 in 1 CARTON 02/15/2010
    12 200 in 1 BOTTLE; Type 0: Not a Combination Product
    13 NDC:0067-2039-77 1 in 1 CARTON 02/15/2010
    13 250 in 1 BOTTLE; Type 0: Not a Combination Product
    14 NDC:0067-2039-07 250 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2010 12/31/2012
    15 NDC:0067-2039-33 1 in 1 CARTON 02/15/2010
    15 300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020802 02/15/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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