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

  • NDC Code(s): 0067-2001-01, 0067-2001-02, 0067-2001-03, 0067-2001-04, view more
    0067-2001-05, 0067-2001-06, 0067-2001-07, 0067-2001-08, 0067-2001-09, 0067-2001-14
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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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:
      • 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

    100CAPLETS

    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    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
    3NDC:0067-2001-021 in 1 CARTON09/30/2020
    324 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2001-031 in 1 CARTON09/30/2020
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2001-041 in 1 CARTON09/30/2020
    550 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2001-061 in 1 CARTON09/30/2020
    6125 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0067-2001-071 in 1 CARTON09/30/2020
    7200 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0067-2001-091 in 1 CARTON09/30/2020
    8250 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0067-2001-012 in 1 POUCH; Type 0: Not a Combination Product01/31/2021
    10NDC:0067-2001-141 in 1 BLISTER PACK01/31/2021
    108 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/15/2019
    Labeler - Haleon US Holdings LLC (079944263)
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