Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel Headache Headache
- Package/Label Principal Display Panel Headache Headache
Overview
Uses temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps
Indications & Usage
Uses temporary relief of minor aches and pains associated with ■ headache ■ common cold ■ sinusitis ■ toothache ■ muscular aches ■ arthritis ■ premenstrual and menstrual cramps
Dosage & Administration
Directions Do not exceed recommended dosage. Drink a full glass of water with each dose. Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Children under 12 years: ask a doctor
Warnings & Precautions
Warnings 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 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) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 8 tablets in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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 take more or for a longer time than directed 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 heart beat.
Purpose
Purpose Pain reliever Pain reliever Pain reliever aid
Do Not Use
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
Stop Use & Ask a Doctor
Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away you feel faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts ringing in 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 new symptoms occur
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 immeaditely. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Storage & Handling
Other information store at 20º-25ºC (68º-77ºF) keep carton for full product information do not use if imprinted safety seal under cap is broken or missing you may report serious side effects to 1-888-952-0050
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