CHILDRENS TYLENOL

CHILDRENS TYLENOL 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 50580-139, application M013, label effective 20260612. 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 reduces, fever relieves, minor aches, pains due, common cold, flu headache, sore throat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache

Directions Directions ■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ shake well before using ■ mL = milliliter ■ find right dose on chart below. If possible, use weight to dose; otherwise, use age. ■ remove the child protective cap and squeeze your child’s dose into the dosing cup ■ repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if ■ pain gets worse or lasts more than 5 days ■ 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. 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 CHILDRENS TYLENOL used for?
Uses Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache

Who makes CHILDRENS TYLENOL?
Kenvue Brands LLC is the labeler of record for CHILDRENS TYLENOL. 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 CHILDRENS TYLENOL 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 CHILDRENS TYLENOL 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 CHILDRENS TYLENOL 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.