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

  • NDC Code(s): 0067-2001-05, 0067-2001-08
  • 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 12, 2019

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

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    a cold
    arthritis
    muscular aches
    toothache
    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

    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
    ringing in the ears or loss of hearing occurs
    painful area is red or swollen
    pain gets worse or lasts for more than 10 days
    fever gets worse or lasts for more than 3 days
    any new symptoms occur

    These could be signs of a serious condition

    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.

  • 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 0067-2001-05

    EXCEDRIN

    EXTRA STRENGTH

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain Reliever/Pain Reliever Aid

    100 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

    ©2018 GSK group of companies or its licensor.

    Trademarks are owned by or licensed to the GSK group of companies.

    62000000032208

    62000000032208_Excedrin ES Caplet_100 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:0067-2001
    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) Size16mm
    FlavorImprint Code E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2001-051 in 1 CARTON03/15/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-2001-081 in 1 CARTON03/15/2019
    2300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/15/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)