Drugplain

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT 160 mg/5mL

Acetaminophen and Dextromethorphan Hydrobromide · SUSPENSION · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT is a suspension containing acetaminophen and dextromethorphan hydrobromide at 160 mg/5mL, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT
Generic Name
Acetaminophen and Dextromethorphan Hydrobromide
NDC Code (Product)
50580-194
Manufacturer
Kenvue Brands LLC
Strength
160 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/26/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use189 reports
vomiting142 reports
drug administered to patient of inappropriate age132 reports
wrong technique in product usage process125 reports
incorrect dose administered123 reports
drug ineffective111 reports
product use issue107 reports
product administered to patient of inappropriate age95 reports
accidental exposure to product by child88 reports
product use in unapproved indication76 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 5 mL 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.

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. 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 b…

Frequently Asked Questions

What is Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT used for?

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT contains Acetaminophen and Dextromethorphan Hydrobromide. It is a suspension taken oral. Consult your doctor for specific uses.

Is Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT a controlled substance?

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT is not classified as a controlled substance by the DEA.

What is the generic name for Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT?

The generic name for Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT is Acetaminophen and Dextromethorphan Hydrobromide. There are 7 other brand versions of Acetaminophen and Dextromethorphan Hydrobromide.

What is the NDC code for Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT 160 mg/5mL?

The NDC (National Drug Code) for Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT 160 mg/5mL is 50580-194, listed by Kenvue Brands LLC.

Product NDC

50580-194

Package NDC

50580-194-01

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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)