Label: MIGRAINE FORMULA- acetaminophen, aspirin and caffeine tablet, coated 

  • NDC Code(s): 55312-374-62, 55312-374-78
  • Packager: Western Family Foods 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 04/14

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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  • Purposes

    Pain reliever

    Pain reliever aid

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  • Use

    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

    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 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. (1-800-222-1222) 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, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Migraine Formula

    ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE TABLETS

    PAIN RELIEVER – PAIN RELIEVER AID

    Gluten Free

    COMPARE TO EXCEDRIN® MIGRAINE active ingredients

    100 COATED CAPLETS†

    †Capsule-Shaped Tablets

    Western Family Migraine Formula 1
    Western Family Migraine Formula 2
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  • INGREDIENTS AND APPEARANCE
    MIGRAINE FORMULA 
    acetaminophen, aspirin, caffeine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55312-374
    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
    CARNAUBA WAX  
    CROSPOVIDONE  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    PROPYLENE GLYCOL  
    SACCHARIN SODIUM  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor Imprint Code L374
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-374-62 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:55312-374-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075794 10/04/2002
    Labeler - Western Family Foods Inc (192166072)
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