Broncolito Children

Broncolito Children is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE. It is labelled by Pharmadel LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55758-520, application M012, label effective 20260623. It is one of 9 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE. 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 DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, common cold, symptoms stuffy, nose nasal, congestion cough, due minor, bronchial irritation, helps loosen. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves common cold symptoms: stuffy nose nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Directions only use the dosage cup included do not exceed 6 doses in 24 hours Age Dose children 6 to under 12 years take 5 mL every 4 hours children 2 to under 6 years take 2.5 mL every 4 hours children under 2 years consult a doctor

Warnings . Do not use 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 taking this product. Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma When using this product do not exceed recommended dosage Stop use and ask a doctor if your child has nervousness, dizziness, or sleeplessness occur a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

FDA lists 9 drug label records with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 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 Broncolito Children used for?
Uses Temporarily relieves common cold symptoms: stuffy nose nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Who makes Broncolito Children?
Pharmadel LLC is the labeler of record for Broncolito Children. 9 FDA label records share the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, 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 Broncolito Children 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 Broncolito Children 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 DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?
Yes. 9 FDA drug label records list DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 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 Broncolito Children 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.