EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE STARCH, CORN STEARIC ACID TALC ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE capsule shaped, biconvex S53
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL image description image description image description
- PRINCIPAL DISPLAY PANEL image description image description image description
Overview
Uses temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual & menstrual cramps
Indications & Usage
Uses temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual & menstrual cramps
Dosage & Administration
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; not more than 8 caplets 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 way. 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 you take ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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
Purposes 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 experience any of the following signs of stomach bleeding ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ ringing in the ears or loss of hearing occurs ■ painful area is red or swollen ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ any new symptoms appear These could be signs of a serious condition
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.
Storage & Handling
Other information ■ store between 20º - 25º C (68º - 77º F)
Questions
Questions or comments? 1-888-333-9792
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