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.
Otc - Purpose
Active ingredient (in each caplet)PurposeAcetaminophen 250 mgPain relieverAspirin 250 mg (NSAID)
nonsteroidal anti-inflammatory drugPain relieverCaffeine 65 mgPain reliever aid
- Temporarily relieves minor aches and pains due to:headachea coldarthritismuscular achessinusitistoothachepremenstrual & menstrual cramps
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.
- Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shockAcetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
- This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
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 reducerwith 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 diseasestomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis or kidney diseaseyou are taking a diureticyou have asthma
Otc - Ask Doctor/Pharmacist
- 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 arthritisany other drug, or are under a doctor's care for any serious conditiona 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or loss of hearing occurspainful area is red or swollenpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysany new symptoms appearThese could be signs of a serious condition
Otc - 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.
Otc - 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. 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 more than directed (see
- Overdose Warning)
- Drink a full glass of water with each doseadults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hourschildren under 12 years: ask a doctor
- Store at controlled room temperature 20º - 25º C (68º - 77º F)read all product information before using. Keep this box for important information
Colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
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