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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/14

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

    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

    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

    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 LABEL Item Code (Source) NDC:0067-8103
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    CARNAUBA WAX  
    FD&C BLUE NO. 1  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    LIGHT MINERAL OIL  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 20  
    POVIDONES  
    PROPYLENE GLYCOL  
    DIMETHICONE  
    SORBITAN MONOLAURATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    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
    2 NDC:0067-8103-30 1 in 1 CARTON
    2 30 in 1 BOTTLE
    3 NDC:0067-8103-91 1 in 1 CARTON
    3 100 in 1 BOTTLE
    4 NDC:0067-8103-83 1 in 1 CARTON
    4 125 in 1 BOTTLE
    5 NDC:0067-8103-92 1 in 1 CARTON
    5 200 in 1 BOTTLE
    6 NDC:0067-8103-33 1 in 1 CARTON
    6 300 in 1 BOTTLE
    7 NDC:0067-8103-50 1 in 1 CARTON
    7 50 in 1 BOTTLE
    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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