Childrens TYLENOL 160 mg/5mL

ACETAMINOPHEN · SUSPENSION · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage

Plain English

Children's Tylenol is an over-the-counter pain reliever and fever reducer containing acetaminophen that comes as an oral suspension. This medication is commonly used to help manage minor aches, pains, and fevers in children.

Key Facts

Brand Name: Childrens TYLENOL
Generic Name: ACETAMINOPHEN
NDC Code (Product): 50580-614
Manufacturer: Kenvue Brands LLC
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 08/01/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,568 reports

fatigue20,455 reports

drug ineffective18,259 reports

pain18,120 reports

nausea17,643 reports

headache16,735 reports

toxicity to various agents15,541 reports

dyspnoea14,581 reports

pyrexia14,331 reports

arthralgia14,320 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache

Dosage & Administration

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 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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings

Warnings Liver warning 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 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) Stop use and ask a doctor if ■ pain gets worse or lasts more than 5 days ■ fever gets worse…

Frequently Asked Questions

What is Childrens TYLENOL used for?

Is Childrens TYLENOL a controlled substance?

Childrens TYLENOL is not classified as a controlled substance by the DEA.

What is the generic name for Childrens TYLENOL?

The generic name for Childrens TYLENOL is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.

What is the NDC code for Childrens TYLENOL 160 mg/5mL?

The NDC (National Drug Code) for Childrens TYLENOL 160 mg/5mL is 50580-614, listed by Kenvue Brands LLC.

Product NDC

50580-614

Package NDC

50580-614-01

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)