TYLENOL Regular Strength

TYLENOL Regular Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50580-496, application M013, label effective 20260527. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. 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 are most often described in connection with: temporarily relieves, minor aches, pains due, headache muscular, pain arthritis, common cold, 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 muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses 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 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. 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 or any of the inactive ingredients in this product Ask a doctor before use if the user has liver disease is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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. Overdose warning 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.

FDA lists 274 drug label records with ACETAMINOPHEN 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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is TYLENOL Regular Strength used for?
Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Who makes TYLENOL Regular Strength?
Kenvue Brands LLC is the labeler of record for TYLENOL Regular Strength. 274 FDA label records share the active ingredient ACETAMINOPHEN, 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 TYLENOL Regular 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 TYLENOL Regular 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?
Yes. 274 FDA drug label records list ACETAMINOPHEN 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 TYLENOL Regular Strength been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.