Label: CHILDRENS TYLENOL- acetaminophen tablet, chewable
- NDC Code(s): 50580-517-24
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 23, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
Warnings
Warnings
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 or pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
When using this product
When using this product do not exceed recommended dose
(see overdose warning)
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Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
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
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
NDC 50580-517-24
NEW
Children’s
TYLENOL®
Acetaminophen
Pain + Fever Ages 2-11 Years
ChewablesPain Reliever
Fever Reducer
Dye-Free
Free Of:
• Dyes
• Ibuprofen
• Aspirin
• Parabens
• High Fructose Corn Syrup
Chew or crush tablets completelybefore swallowing
24 Chewable Tablets
160 mg eachActual Size
Wild Berry
Flavor
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INGREDIENTS AND APPEARANCE
CHILDRENS TYLENOL
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-517 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ACETIC ACID (UNII: Q40Q9N063P) CELLULOSE ACETATE (UNII: 3J2P07GVB6) ETHYL ACETATE (UNII: 76845O8NMZ) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white (White to Off-White) Score 2 pieces Shape ROUND Size 15mm Flavor BERRY Imprint Code TY;160;HALF;HALF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-517-24 1 in 1 CARTON 09/01/2025 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/01/2025 Labeler - Kenvue Brands LLC (118772437)
