Childrens TYLENOL

Acetaminophen · Suspension · Oral

Over the counter Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist Histamine-1 Receptor Antagonist

Active ingredient

Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant

Purpose

Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant

Uses

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough 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. to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Stop use and ask a doctor if pain or cough 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 cough comes back or occurs with rash or headache that lasts 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.

Do not use

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. to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use

Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children

Stop use and ask a doctor

Stop use and ask a doctor if pain or cough 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 cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

Keep out of reach of children

Keep out of reach of children.

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 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive ingredients

Inactive ingredients anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions?

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

Label text from the FDA structured product label by Kenvue Brands LLC (revised Aug 25, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Childrens TYLENOL NDC products (16)

NDCStrength & formLabelerType
50580-139Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-170Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-194Acetaminophen 160 mg/5mL; Dextromethorphan Hydrobromide 5 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-245Acetaminophen 160 mg/5mL; Chlorpheniramine Maleate 1 mg/5mL; Dextromethorphan Hydrobromide 5 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-299Acetaminophen 160 mg/5mL; Chlorpheniramine Maleate 1 mg/5mL; Dextromethorphan Hydrobromide 5 mg/5mL; Phenylephrine…
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-424Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-456Acetaminophen 160 mg/5mL; Chlorpheniramine Maleate 1 mg/5mL; Dextromethorphan Hydrobromide 5 mg/5mL; Phenylephrine…
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-460
Kit
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-509Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-517Acetaminophen 160 mg/1
Tablet, Chewable
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-521Acetaminophen 160 mg/1
Tablet, Chewable
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-522Acetaminophen 160 mg/1
Tablet, Chewable
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-555Acetaminophen 160 mg/1
Powder
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-579Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-612Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG
50580-614Acetaminophen 160 mg/5mL
Suspension
Kenvue Brands LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Childrens TYLENOL used for?

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever

Who makes Childrens TYLENOL?

Childrens TYLENOL is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.