Acetaminophen, Aspirin, Caffeine

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 82804-008

Application: M013

Effective: 20231101

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps

Directions ■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over: ■ take 2 caplets every 6 hours ■ do not take more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor

Not available.

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: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing) 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. Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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 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 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 have asthma ■ you are taking a diuretic Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for diabetes, gout, or arthritis ■ taking any other drug or are under a doctor’s care for any serious condition Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ have bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ an allergic reaction occurs. Seek medical help right away. ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ painful area is red or swollen ■ 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 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.

Not available.