ValuMeds Extra Strength Headache Relief
Acetaminophen, Aspirin, Caffeine · Tablet · Oral
Active ingredient
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
Purpose
Purpose Pain reliever Pain reliever Pain reliever aid
Uses
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
Warnings
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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 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 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 heart disease, liver cirrhosis or kidney disease you are taking a diuretic you have high blood pressure you have asthma Ask a doctor or pharmacist before use if you are any other drug containing an NSAID (prescription or non-prescription) 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 In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. 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
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 heart disease, liver cirrhosis or kidney disease you are taking a diuretic you have high blood pressure you have asthma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are any other drug containing an NSAID (prescription or non-prescription) 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 breast-feeding
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
Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
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
Inactive ingredients
Inactive ingredients colloidal silicon dioxide, hypermellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, talc
Questions?
Questions or comments? contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
Label text from the FDA structured product label by Cabinet Health P.B.C. (revised Jan 31, 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
ValuMeds Extra Strength Headache Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 82725-1023 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Caffeine 65 mg/1 Tablet | Cabinet Health P.B.C. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is ValuMeds Extra Strength Headache Relief used for?
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
Who makes ValuMeds Extra Strength Headache Relief?
ValuMeds Extra Strength Headache Relief is listed by 1 labeler in the FDA NDC directory, including Cabinet Health P.B.C..