TYLENOL For Children Plus Adults

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
TYLENOL For Children Plus Adults
Generic name
ACETAMINOPHEN
Manufacturer
Kenvue Brands LLC
Product type
HUMAN OTC DRUG
SPL set ID
5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42
SPL ID
35a3c165-116d-b171-e063-6394a90a8abd
Version
5
Effective date
2025-05-21
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:38:55
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Liver warning This product contains acetaminophen. 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. 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 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 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 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. Directions ■ do not give more than directed (see overdose warning) ■ shake well before using ■ mL = milliliter ■ Children 2 years to under 12 years: ■ find right dose on chart below. If possible, use weight to dose; otherwise, use age. ■ remove the child protective cap and squeeze the dose into the dosing cup ■ repeat dose every 4 hours while symptoms last ■ do not take more than 5 times in 24 hours unless directed by a doctor ■ do not take for more than 5 days unless directed by a doctor Weight (lb) Age (years) 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 ■ Adults and children 12 years and over: ■ take 20 mL (2 x 10 mL) every 4 hours while symptoms last. For adult dosing,the dosing cup needs to be filled to 10 mL line twice. ■ do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless 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 table

<table border="6" width="100%"><tbody><tr><td><content styleCode="bold">Weight (lb)</content></td><td><content styleCode="bold">Age (years)</content></td><td><content styleCode="bold">Dose (mL)*</content></td></tr><tr><td>under 24</td><td>under 2 years</td><td>ask a doctor</td></tr><tr><td>24-35 lbs</td><td>2-3 years</td><td>5 mL</td></tr><tr><td>36-47 lbs</td><td>4-5 years</td><td>7.5 mL</td></tr><tr><td>48-59 lbs</td><td>6-8 years</td><td>10 mL</td></tr><tr><td>60-71 lbs</td><td>9-10 years</td><td>12.5 mL</td></tr><tr><td>72-95 lbs</td><td>11 years</td><td>15 mL</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.