Robitussin Direct Cough

Robitussin Direct Cough is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Haleon US Holdings LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0031-9302, application M012, label effective 20260730. 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. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over take 1 capsule (15 mg) every 4 hours, as required children under 12 years do not use

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 a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 Robitussin Direct Cough used for?
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Who makes Robitussin Direct Cough?
Haleon US Holdings LLC is the labeler of record for Robitussin Direct 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 Robitussin Direct 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 Robitussin Direct 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 Robitussin Direct 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.