Label: EXCEDRIN EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin (nsaid), and caffeine tablet, film coated

  • NDC Code(s): 0067-2000-02, 0067-2000-07, 0067-2000-10, 0067-2000-20, view more
    0067-2000-24, 0067-2000-30, 0067-2000-33, 0067-2000-50, 0067-2000-77, 0067-2000-83, 0067-2000-91, 0067-2000-94
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 2, 2017

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

  • Active ingredient (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

    Pain reliever aid

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  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    a cold
    arthritis
    muscular aches
    toothache
    premenstrual & menstrual cramps
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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.

    Allegy 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 8 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 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

    Ask a doctor or pharmacist before use if you are

    taking

    a prescription drug for diabetes, gout, or arthritis
    any other drug, or are under a doctor’s care for any serious condition

    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
    drink a full glass of water with each dose
    adults and children 12 years and over: take 2 caplets  every 6 hours; not more than 8 caplets  in 24 hours
    children under 12 years: 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

    1-800-452-0051

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  • Principal Display Panel

    NDC 0067-2000-10

    EXCEDRIN

    EXTRA STRENGTH

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain Reliever/Pain Reliever Aid

    10 CAPLETS

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL INPRINTED WITH “SEALED forYOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by:GSK Consumer Healthcare

    Warren, NJ 07059

    2015 GSK or its licensor.

    Visit us at www.excedrin.com

    46172146

    Excedrin Extra Strength 10 count caplet carton
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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  EXTRA STRENGTH PAIN RELIEVER
    acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2000
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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 E
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2000-02 2 in 1 POUCH; Type 0: Not a Combination Product 09/27/2006
    2 NDC:0067-2000-10 1 in 1 CARTON 09/27/2006
    2 10 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0067-2000-24 1 in 1 CARTON 09/27/2006
    3 24 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0067-2000-30 1 in 1 CARTON 09/27/2006
    4 30 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0067-2000-50 1 in 1 CARTON 09/27/2006
    5 50 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0067-2000-91 1 in 1 CARTON 09/27/2006
    6 100 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0067-2000-94 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2006
    8 NDC:0067-2000-83 1 in 1 CARTON 09/27/2006
    8 125 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:0067-2000-20 1 in 1 CARTON 09/27/2006
    9 200 in 1 BOTTLE; Type 0: Not a Combination Product
    10 NDC:0067-2000-77 1 in 1 CARTON 09/27/2006
    10 250 in 1 BOTTLE; Type 0: Not a Combination Product
    11 NDC:0067-2000-07 250 in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2006
    12 NDC:0067-2000-33 1 in 1 CARTON 09/27/2006
    12 300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/27/2006
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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