Tension Headache Aspirin-Free

Tension Headache Aspirin-Free is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CAFFEINE. It is labelled by Rite Aid Corporation taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 11822-0428, application M013, label effective 20260806. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, 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, CAFFEINE are most often described in connection with: temporarily relieves, minor aches, pains due, headache muscular. 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 muscular aches

Directions do not take more than directed adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours. children under 12 years: ask a doctor

Warnings 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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur 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 These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental 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.

FDA lists 3 drug label records with ACETAMINOPHEN, 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 Tension Headache Aspirin-Free used for?
Uses temporarily relieves minor aches and pains due to: headache muscular aches

Who makes Tension Headache Aspirin-Free?
Rite Aid Corporation is the labeler of record for Tension Headache Aspirin-Free. 3 FDA label records share the active ingredient ACETAMINOPHEN, 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 Tension Headache Aspirin-Free 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 Tension Headache Aspirin-Free 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, CAFFEINE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, 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 Tension Headache Aspirin-Free 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.