Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack

Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN. It is labelled by Reckitt Benckiser LLC and marketed as a human otc drug product. Identifiers on file: NDC 63824-944, application M012, label effective 20260518. 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, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, nasal congestion, runny nose. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold and flu symptoms minor aches and pains headache sore throat nasal congestion runny nose sneezing cough controls cough to help your child get to sleep 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 ) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period children under 6 years of age: do not use

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 with any other product containing diphenhydramine, even one used on the skin 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. Ask a doctor before use if the child has liver disease heart disease diabetes high blood pressure thyroid disease glaucoma a breathing problem such as chronic bronchitis 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 the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed (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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, 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 right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

5 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 Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack used for?
Uses temporarily relieves these common cold and flu symptoms minor aches and pains headache sore throat nasal congestion runny nose sneezing cough controls cough to help your child get to sleep temporarily reduces fever

Who makes Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack?
Reckitt Benckiser LLC is the labeler of record for Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack.

Is Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack 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.

Has Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack been recalled?
5 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.