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ExcedrinExtra Strength Pain Reliever

Dosage form
TABLET, FILM COATED
Labeler
Haleon US Holdings LLC
Label updated
2024-04-22
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · ASPIRIN · CAFFEINE
View original label and images on DailyMed ↗
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:
    • oheadache
    • oa cold
    • oarthritis
    • omuscular aches
    • otoothache
    • opremenstrual & 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

[Image in the official label — see DailyMed source]

DailyMed Set ID: a71074a6-cc19-4bb3-8c84-4e82a8906801 · Version 12
NDC: 0067-2000