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 ingredients (in each caplet)PurposeAcetaminophen 250 mgPain relieverAspirin (NSAID
1) 250 mg
Pain relieverCaffeine 65 mgPain reliever aid1nonsteroidal anti-inflammatory drug
- Temporarily relieves minor aches and pains due to:
- Headachea coldarthritismuscular achestoothachepremenstrual and 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.
- Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away
- Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shock
- 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 you:are 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 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 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.
Ask A 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
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking a prescription drug for:
- Diabetesgoutarthritistaking 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 loss of hearing occursredness or swelling is presentpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysnew symptoms occurThese 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 (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 more than directeddrink a full glass of water with each doseadults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hourschildren under 12 years: ask a doctor
- Store between 20-25°C (68-77°F) in a dry placeretain carton for complete product information
Carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
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