Headache Relief, Extra Strength
acetaminophen, aspirin, caffeine tablet, film coated · Tablet, Film Coated · Oral
Active ingredient
Active ingredients Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug Purpose Purpose Pain reliever Pain reliever Pain reliever aid
Purpose
Purpose Purpose Pain reliever Pain reliever Pain reliever aid
Uses
Uses Uses temporarily relieves minor aches and pains due to: a cold toothache arthritis muscular aches headache premenstrual and menstrual cramps
Warnings
Warnings Warnings Reye’s syndrome 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 Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Allergy alert 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. Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product are age 60 or older take more or for a longer time than directed Caffeine warning 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 heartbeat. Do not use Do not use if you have ever had an allergic reaction to 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 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis Stop use and ask a doctor if 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present any new symptoms appear If pregnant or breast-feeding 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 Keep out of reach of children. 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 for children even if you do not notice any signs or symptoms.
Do not use
Do not use Do not use if you have ever had an allergic reaction to 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 a doctor before use if 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis
Stop use and ask a doctor
Stop use and ask a doctor if 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present any new symptoms appear
Pregnancy or breast-feeding
If pregnant or breast-feeding 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
Keep out of reach of children Keep out of reach of children. 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 for children even if you do not notice any signs or symptoms.
Directions
Directions Directions do not take 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. Do not take more than 8 caplets in 24 hours. children under 12 years: ask a doctor
Inactive ingredients
Inactive ingredients Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions?
Questions or comments Questions or comments? 1-877-507-6516
Label text from the FDA structured product label by Lil' Drug Store Products, Inc. (revised Dec 5, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Aspirin in 1 product
- Caffeine in 1 product
Headache Relief, Extra Strength NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 66715-5641 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet, Film Coated | Lil' Drug Store Products, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Headache Relief, Extra Strength used for?
Uses Uses temporarily relieves minor aches and pains due to: a cold toothache arthritis muscular aches headache premenstrual and menstrual cramps
Who makes Headache Relief, Extra Strength?
Headache Relief, Extra Strength is listed by 1 labeler in the FDA NDC directory, including Lil' Drug Store Products, Inc..