Active Ingredients: (in each caplet) Acetaminophen 250 mg - Pain reliever. Aspirin 250 mg (NSAID*) - Pain reliever. Diphenhydramine citrate 38 mg - Nighttime sleep-aid *nonsteroidal anti-inflammatory drug ; Inactive Ingredients: Benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate.
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, or 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), or shock. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 2 caplets in 24 hours, which is the maximum daily amount, with other drugs containing acetaminophen, or 3 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 older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, or take more or for a longer time than directed. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Do not use with any other product containing diphenhydramine, even one used on skin. Do not use in children under 12 years of age. 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma, you have glaucoma, you have a breathing problem such as emphysema or chronic bronchitis, or you have trouble urinating due to an enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes, gout, or arthritis. Ask a doctor or pharmacist before use if you are taking any other drug, or are under a doctor's care for any serious condition, any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer, or sedatives or tranquilizers. When using this product drowsiness will occur, avoid alcoholic drinks, and do not drive a motor vehicle or operate machinery. Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. Stop use and ask a doctor if pain gets worse or lasts for more than 10 days, painful area is red or swollen, ringing in the ears or a loss of hearing occurs, or any new symptoms occur. 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 three 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
