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Excedrin Extra Strength Headache

acetaminophen, aspirin (nsaid), caffeine · Excedrin Extra Strength Headache is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin (nsaid), caffeine, made by Haleon US Holdings LLC.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
1
+ 2 repackager labels

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

Drug facts

Generic name
acetaminophen, aspirin (nsaid), caffeine
Active ingredients
Acetaminophen, Aspirin, Caffeine
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet, film coated
Label holder
Haleon US Holdings LLC
FDA application
M013
Label updated
12/27/2025

Active ingredients

(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever Pain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • A cold
  • Arthritis
  • Muscular aches
  • Toothache
  • Premenstrual and menstrual cramps

Directions

  • Do not use more than directed
  • Drink a full glass of water with each dose
  • Adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • Children under 12 years: ask a doctor

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 at 20 weeks or later in 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.

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

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

  • 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.

Pregnancy or breastfeeding

Ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

Inactive ingredients

(24 ct)

Inactive ingredients (100 ct) corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

1-800-468-7746

Forms and strengths

From the FDA NDC Directory · 4 product codes

Dosage formStrengthRouteNDCs
Tablet, film coated250 mg / 250 mg / 65 mgoral4

Manufacturers and labels

3 FDA labels · 2 from repackagers

  • Haleon US Holdings LLCShown hereM013 · Label 01/28/2024 · NDC 0067-2002, 0067-2003Full label
Repackager labels (2)
  • R J General Corporation11/17/2025
  • Select Consumer Group12/27/2025

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Excedrin Extra Strength Headache: common questions

What is Excedrin Extra Strength Headache used for?
• temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps
Is Excedrin Extra Strength Headache a prescription drug?
No. Excedrin Extra Strength Headache is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Excedrin Extra Strength Headache?
Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength.
Who makes Excedrin Extra Strength Headache?
Haleon US Holdings LLC lists Excedrin Extra Strength Headache with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/27/2025 · Label text is shown as published by the manufacturer. Not medical advice