Guaifenesin and Dextromethorphan Hydrobromide

Guaifenesin and Dextromethorphan Hydrobromide is an FDA-registered drug product whose active ingredient is GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by CVS PHARMACY, INC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51316-600, application ANDA214781, label effective 20260420. It is one of 9 FDA drug label records sharing the active ingredient GUAIFENESIN AND 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 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs, productive temporarily, relieves cough. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use

Warnings Do not use for children under 12 years of age 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, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed 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 illness. 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 (1-800-222-1222).

FDA lists 9 drug label records with GUAIFENESIN AND 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 Guaifenesin and Dextromethorphan Hydrobromide used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Who makes Guaifenesin and Dextromethorphan Hydrobromide?
CVS PHARMACY, INC is the labeler of record for Guaifenesin and Dextromethorphan Hydrobromide. 9 FDA label records share the active ingredient GUAIFENESIN AND 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 Guaifenesin and Dextromethorphan Hydrobromide 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 Guaifenesin and Dextromethorphan Hydrobromide 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 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE?
Yes. 9 FDA drug label records list GUAIFENESIN AND 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 Guaifenesin and Dextromethorphan Hydrobromide 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.