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

  • NDC Code(s): 0067-8103-24, 0067-8103-30, 0067-8103-33, 0067-8103-50, view more
    0067-8103-83, 0067-8103-91, 0067-8103-92
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 06/15

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

  • Active ingredient

    Acetaminophen 250 mg

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  • Purpose

    Pain reliever

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  • Active Ingredient

    Aspirin 250 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Active Ingredient

    Caffeine 65 mg

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  • Purpose

    Pain reliever aid

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  • Uses

    ● treats migraines

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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

    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 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 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

    carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregeletanized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

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  • Questions

    1-800-468-7746

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  MIGRAINE
    acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8103
    Route of Administration ORAL DEA Schedule     
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE ((capsule shaped tablet)) Size 17mm
    Flavor Imprint Code EX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-8103-24 1 in 1 CARTON
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0067-8103-30 1 in 1 CARTON
    2 30 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0067-8103-91 1 in 1 CARTON
    3 100 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0067-8103-83 1 in 1 CARTON
    4 125 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0067-8103-92 1 in 1 CARTON
    5 200 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0067-8103-33 1 in 1 CARTON
    6 300 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0067-8103-50 1 in 1 CARTON
    7 50 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075794 10/22/2012
    Labeler - Novartis Consumer Health, Inc. (879821635)
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