Mucinex Maximum Strength

Mucinex Maximum Strength is an FDA-registered drug product whose active ingredient is GUAIFENESIN. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63824-023, application NDA021282, label effective 20260527. It is one of 98 FDA drug label records sharing the active ingredient GUAIFENESIN. 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 are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs. 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

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 the timing of meals adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 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 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) 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.

FDA lists 98 drug label records with GUAIFENESIN 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 Maximum Strength used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Who makes Mucinex Maximum Strength?
Reckitt Benckiser LLC is the labeler of record for Mucinex Maximum Strength. 98 FDA label records share the active ingredient GUAIFENESIN, 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 Maximum Strength 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 Maximum Strength 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?
Yes. 98 FDA drug label records list GUAIFENESIN 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 Maximum Strength 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.