MUCINEX INSTASOOTHE COUGH

MUCINEX INSTASOOTHE COUGH is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-267, application M012, label effective 20260803. It is one of 8 FDA drug label records sharing the active ingredient 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 DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, common cold, inhaled irritants, helps reduce, intensity coughing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily: ■ relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ helps reduce the intensity of coughing

Directions Label

Warnings Do Not Use ■ if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use.

FDA lists 8 drug label records with 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.

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 INSTASOOTHE COUGH used for?
Uses temporarily: ■ relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ helps reduce the intensity of coughing

Who makes MUCINEX INSTASOOTHE COUGH?
Reckitt Benckiser LLC is the labeler of record for MUCINEX INSTASOOTHE COUGH. 8 FDA label records share the active ingredient 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 MUCINEX INSTASOOTHE COUGH 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 MUCINEX INSTASOOTHE COUGH 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?
Yes. 8 FDA drug label records list 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 MUCINEX INSTASOOTHE COUGH 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.