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General MedicationsORALHigh Alert

Headache Relief Extra Strength

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Standard Dose
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 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor
Max Dose
See official label
Primary Use
Use(s) temporarily relieves minor aches and pains due to headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Summary

Indications and usage Use(s) temporarily relieves minor aches and pains due to headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps Dosage and 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 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor Warnings and cautions 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.

Structured Monograph

Clinical summary

Indications and usage Use(s) temporarily relieves minor aches and pains due to headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps Dosage and 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 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor Warnings and cautions 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. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or 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 are taking a diuretic you have asthma Ask a doctor or pharmacist before use if taking a prescription drug for diabetes, gout, or arthritis taking any other drug, or 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 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 ever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice the signs or symptoms.

Monitoring

  • 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.

Interaction Notes

  • Review official label interaction section.
Headache Relief Extra Strength (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) | Drug Monograph | MedicHelpline