CHILDRENS TYLENOL- acetaminophen tablet, chewable

Childrens TYLENOL by

Drug Labeling and Warnings

Childrens TYLENOL by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

• temporarily reduces fever

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

Ask a doctor before use if your child has liver disease

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)

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.

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

• store between 20-25°C (68-77°F).
• do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

acesulfame potassium, acetic acid, cellulose acetate, ethyl acetate, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, povidone, sodium starch glycolate, sucralose

Questions or comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

CHILDRENS TYLENOL 
acetaminophen tablet, chewable

Product 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)