Headache Relief Extra Strength

Headache Relief Extra Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, ASPIRIN, CAFFEINE. It is labelled by Safeway, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 21130-586, application M013, label effective 20260819. It is one of 27 FDA drug label records sharing the active ingredient ACETAMINOPHEN, ASPIRIN, CAFFEINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, ASPIRIN, CAFFEINE are most often described in connection with: temporarily relieves, minor aches, pains due, headache cold, arthritis muscular, toothache premenstrual, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches 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 geltabs every 6 hours; do not take more than 8 geltabs in 24 hours children under 12 years: do not use unless directed by a doctor

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 severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) 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 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 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 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 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 more than 3 days any new symptoms occur 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 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 27 drug label records with ACETAMINOPHEN, ASPIRIN, CAFFEINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Headache Relief Extra Strength used for?
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

Who makes Headache Relief Extra Strength?
Safeway, Inc. is the labeler of record for Headache Relief Extra Strength. 27 FDA label records share the active ingredient ACETAMINOPHEN, ASPIRIN, CAFFEINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Headache Relief Extra Strength come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Headache Relief Extra Strength prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, ASPIRIN, CAFFEINE?
Yes. 27 FDA drug label records list ACETAMINOPHEN, ASPIRIN, CAFFEINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Headache Relief Extra Strength been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.