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 May 15, 2023

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  • Active ingredient (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

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

  • 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
  • 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
  • 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

  • Questions or comments?

    1-800-452-0051

  • 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 for YOUR 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

    46172146_Excedrin Extra Strength caplets_10 ct.JPG
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  EXTRA STRENGTH PAIN RELIEVER
    acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White) Scoreno score
    ShapeCAPSULE (Capsule-Shaped Tablet) Size18mm
    FlavorImprint Code E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2000-022 in 1 POUCH; Type 0: Not a Combination Product09/27/2006
    2NDC:0067-2000-101 in 1 CARTON09/27/2006
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2000-241 in 1 CARTON09/27/2006
    324 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2000-301 in 1 CARTON09/27/2006
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2000-501 in 1 CARTON09/27/2006
    550 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2000-911 in 1 CARTON09/27/2006
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0067-2000-94100 in 1 BOTTLE; Type 0: Not a Combination Product09/27/200612/31/2014
    8NDC:0067-2000-831 in 1 CARTON09/27/2006
    8125 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0067-2000-201 in 1 CARTON09/27/2006
    9200 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0067-2000-771 in 1 CARTON09/27/2006
    10250 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:0067-2000-07250 in 1 BOTTLE; Type 0: Not a Combination Product09/27/200612/31/2014
    12NDC:0067-2000-331 in 1 CARTON09/27/2006
    12300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/27/2006
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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