Headache Relief Extra Strength

Generic: ACETAMINOPHEN, ASPIRIN, CAFFEINE

Over-the-Counter DrugORAL

Drug Information

Brand Name
Headache Relief Extra Strength
Generic Name
ACETAMINOPHEN, ASPIRIN, CAFFEINE
Manufacturer
Meijer Distribution Inc
Product Type
Over-the-Counter Drug
Route
ORAL
Application Number
04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca2

Pharmacological Class

Nonsteroidal Anti-inflammatory Drug [EPC]

Active Ingredients

Indications & Usage

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

Warnings

Warnings Reyeโ€™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: shock facial swelling hives asthma (wheezing) Allergy alert: Acetaminophen may cause s...

Read full warnings

Warnings Reyeโ€™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: shock facial swelling hives 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 more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug 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 heartbeat. Do not use if you have ever had an allergic reaction to 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 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 have bloody or black stools vomit blood have stomach pain that does not get better ringing in the ears or loss of hearing occurs redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Adverse Reactions

No specific warnings reported by FDA for this product.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Headache Relief Extra Strength - Side Effects, Warnings, Uses | FDA Drug Database