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Walgreens Headache Relief Extra Strength
acetaminophen 250mg, aspirin 250mg and caffeine 65mg · Walgreens Headache Relief Extra Strength is a central nervous system stimulant (over-the-counter) containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg, made by Walgreens.
- Type
- Over the counter
- Drug class
- Central Nervous System Stimulant
- Route
- Oral
- Manufacturers
- 1
Temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual and menstrual cramps
Drug facts
- Generic name
- acetaminophen 250mg, aspirin 250mg and caffeine 65mg
- Active ingredients
- Acetaminophen, Aspirin, Caffeine
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- How it works
- Cyclooxygenase Inhibitors
- Dosage forms
- Tablet, coated
- Label holder
- Walgreens
- FDA application
- M013
- Label updated
- 05/18/2026
Active ingredients
(in each softgel) 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 (see overdose warning)
- Drink a full glass of water with each dose
- Adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs 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 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 geltabs 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 occasional rapid heartbeat.
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 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
- 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 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Inactive ingredients
Corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin
Questions?
1-888-333-9792 Monday-Friday 8am-4pm EST
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, coated | 65 mg / 250 mg / 250 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- WalgreensShown hereM013 · Label 05/18/2026 · NDC 0363-6693Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
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Walgreens Headache Relief Extra Strength: common questions
- What is Walgreens Headache Relief Extra Strength used for?
- Temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual and menstrual cramps
- Is Walgreens Headache Relief Extra Strength a prescription drug?
- No. Walgreens Headache Relief Extra Strength is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Walgreens Headache Relief Extra Strength?
- 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 Walgreens Headache Relief Extra Strength?
- Walgreens lists Walgreens Headache Relief Extra Strength with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/18/2026 · Label text is shown as published by the manufacturer. Not medical advice