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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
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- 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 form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 250 mg / 250 mg / 65 mg | oral | 2 |
| Tablet, coated | 250 mg / 250 mg / 65 mg | oral | 1 |
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
- Class IIDrugOngoing01/14/2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster...SpecGx, LLC · 2 products · Failed Tablet/Capsule Specification: There is a potential for the...
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
- Class IIDrugOngoing11/05/2025TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer...Kenvue Brands LLC · Defective Container
- Class IIDrugOngoing09/03/2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter...Baxter Healthcare Corporation · Discoloration
- Class IIDrugOngoing06/25/2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry...Aurobindo Pharma USA Inc · cGMP deviations: Due to confirmed consumer complaints received...
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