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Extra Strength Headache Relief

acetaminophen, aspirin, caffeine · Extra Strength Headache Relief is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin, caffeine, made by 2 manufacturers.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
2

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

Drug facts

Generic name
acetaminophen, aspirin, caffeine
Active ingredients
Acetaminophen, Aspirin, Caffeine
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet, Tablet, coated
Label holder
WALGREENS
FDA application
M013
Label updated
01/16/2026

Active ingredients

(in each tablet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid

Purpose

Active ingredient (in each tablet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid

Uses

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

Directions

Do not use more than directed (see Overdose Warning) 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

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 Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets 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 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 any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug Stop use and ask 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 appear 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 Overdose Warning 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. 1(800) 222-1222

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

Ask 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 any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug

Stop use and ask a doctor

Stop use and ask 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 appear 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 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

Keep out of reach of children

Other information

Each caplet contains: Magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using. Keep this box for important information

Inactive ingredients

Colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc

Questions?

1-888-333-9792

Forms and strengths

From the FDA NDC Directory · 3 product codes

Dosage formStrengthRouteNDCs
Tablet250 mg / 250 mg / 65 mgoral2
Tablet, coated250 mg / 250 mg / 65 mgoral1

Manufacturers and labels

3 FDA labels

  • WALGREENSShown hereM013 · Label 01/16/2026 · NDC 0363-8992Full label
  • WAL-MART STORES INCM013 · Label 07/16/2025 · NDC 79903-044Full label
  • WALGREENSM013 · Label 01/16/2026 · NDC 0363-7214Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Extra Strength Headache Relief: common questions

What is Extra Strength Headache Relief used for?
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
Is Extra Strength Headache Relief a prescription drug?
No. Extra Strength Headache Relief is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Extra Strength Headache Relief?
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 Extra Strength Headache Relief?
2 manufacturers list Extra Strength Headache Relief with the FDA, including WALGREENS, WAL-MART STORES INC.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/16/2026 · Label text is shown as published by the manufacturer. Not medical advice