Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Childrens Tylenol (NDC 50580-517). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each chewable tablet), purpose, uses, warnings, liver warning, allergy alert, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Acetaminophen 160 mg
Pain reliever/fever reducer
Warnings
This product contains acetaminophen. Severe liver damage may occur if your child takes
acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
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)
These could be signs of a serious condition.
Keep out of reach of children.
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.
| Weight (lb) | Age (yr) | Dose (tablets)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 1 tablet |
| 36-47 lbs | 4-5 years | 1½ tablets |
| 48-59 lbs | 6-8 years | 2 tablets |
| 60-71 lbs | 9-10 years | 2½ tablets |
| 72-95 lbs | 11 years | 3 tablets |
*or as directed by a doctor
acesulfame potassium, acetic acid, cellulose acetate, ethyl acetate, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, povidone, sodium starch glycolate, sucralose
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
NDC 50580-517-24
NEW
Children’s
TYLENOL®
Acetaminophen
Pain + Fever Ages 2-11 Years
Chewables
Pain Reliever
Fever Reducer
Dye-Free
Free Of:
• Dyes
• Ibuprofen
• Aspirin
• Parabens
• High Fructose Corn Syrup
Chew or crush tablets completely
before swallowing
24 Chewable Tablets
160 mg each
Actual Size
Wild Berry
Flavor
* Please review the disclaimer below.