The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Gelcap)
Acetaminophen 250 mgAspirin 250 mg (NSAID)*Caffeine 65 mg*nonsteroidal anti-inflammatory drug
Pain relieverPain relieverPain reliever aid
- Temporarily relieves minor aches and pains due to:a coldheadachearthritismuscular achestoothachepremenstrual and menstrual cramps
- 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:shockfacial swellinghivesasthma (wheezing)Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youhave had stomach ulcers or bleeding problemstake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]take a blood thinning (anticoagulant) or steroid drugare age 60 or olderhave 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedCaffeine 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 reducerwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If
- Stomach bleeding warning applies to youyou have liver diseaseyou have asthmayou have a history of stomach problems, such as heartburnyou are taking a diureticyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking a prescription drug for diabetes, gout, or arthritistaking any other drug or are under a doctor’s care for any serious condition
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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or a loss of hearing occurspain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysredness or swelling is presentnew symptoms occurThese 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than directeddrink a full glass of water with each doseadults and children 12 years and overtake 2 gelcaps every 6 hoursdo not take more than 8 gelcaps in 24 hourschildren under 12 years: ask a doctor
- Avoid high humiditysee end flap for expiration date and lot numberstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
* Please review the disclaimer below.