Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE

Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50580-245, application M012, label effective 20260825. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, following cold, flu symptoms, minor aches, pains headache, sore throat, runny nose, reduces fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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.

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.

FDA lists 2 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE 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 COLD plus COUGH plus RUNNY NOSE?
Kenvue Brands LLC is the labeler of record for Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE. 2 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.