Cough and Runny Nose Childrens Plus

Cough and Runny Nose Childrens Plus is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by TOP CARE (Topco Associates LLC) taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 36800-297, application M012, label effective 20260601. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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, DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, following cold, flu symptoms, minor aches, pains sore, throat cough, 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 sore throat cough sneezing and runny nose headache temporarily reduces fever

Directions this product does not contain directions or complete warnings for adult use. mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount with other drugs contaning 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 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. with any other drug containing acetaminophen (prescription or non-prescription). 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 the child has liver disease glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as children even if you do not notice any signs or symptoms.

FDA lists 2 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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.

What is Cough and Runny Nose Childrens Plus used for?
Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache temporarily reduces fever

Who makes Cough and Runny Nose Childrens Plus?
TOP CARE (Topco Associates LLC) is the labeler of record for Cough and Runny Nose Childrens Plus. 2 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 Cough and Runny Nose Childrens Plus 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 Cough and Runny Nose Childrens Plus 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, DEXTROMETHORPHAN HYDROBROMIDE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 Cough and Runny Nose Childrens Plus been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.