Label: EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE- acetaminophen, aspirin, and caffeine tablet, film coated

  • NDC Code(s): 29485-8028-6
  • Packager: Mechanical Servants LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 7, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purposes
    *
    nonsteroidal anti-inflammatory drug
    Acetaminophen 250 mg Pain reliever
    Aspirin 250 mg (NSAID)* Pain reliever
    Caffeine 65 mg 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

    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. 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)
    • 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?

    1-800-452-0051

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  • SPL UNCLASSIFIED SECTION

    Packaged and distributed by Convenience Valet® with the permission of
    GSK Consumer Healthcare, Warren, NJ 07059

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  • PRINCIPAL DISPLAY PANEL - 2 Caplet Packet Carton

    EXCEDRIN®
    MIGRAINE

    Acetaminophen,
    Aspirin (NSAID) and Caffeine

    Pain Reliever / Pain Reliever Aid

    3 Packets of 2 Caplets

    Principal Display Panel - 2 Caplet Packet Carton
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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE 
    acetaminophen, aspirin, and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-8028
    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 (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
    Color WHITE Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29485-8028-6 3 in 1 CARTON 02/15/2010
    1 2 in 1 POUCH; 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 - Mechanical Servants LLC (005530951)
    Establishment
    Name Address ID/FEI Business Operations
    Mechanical Servants LLC 005530951 REPACK(29485-8028) , RELABEL(29485-8028)
    Establishment
    Name Address ID/FEI Business Operations
    GlaxoSmithKline 046877908 MANUFACTURE(29485-8028)
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