Mucinex Sinus Max Clear and Cool Severe Congestion

Mucinex Sinus Max Clear and Cool Severe Congestion is an FDA-registered drug product whose active ingredient is OXYMETAZOLINE HCI. It is labelled by Reckitt Benckiser LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 72854-218, application M012, label effective 20260519. It is one of 2 FDA drug label records sharing the active ingredient OXYMETAZOLINE HCI. 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 OXYMETAZOLINE HCI are most often described in connection with: temporarily relieves, nasal congestion, due cold, hay fever, upper respiratory, allergies promotes, sinus drainage, pressure helps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ■ temporarily relieves nasal congestion due to: ■ a cold ■ hay fever or other upper respiratory allergies ■ promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure ■ helps clear nasal passages; shrinks swollen membranes

Directions ■ adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. ■ children under 6 years of age: consult a doctor. Shake well before use. To open, hold by the white grips then squeeze, push down firmly and turn cap counterclockwise. Before using for the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers.Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply.

Warnings Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland When using this product ■ do not exceed recommended dosage ■ do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. ■ this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge ■ the use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist

FDA lists 2 drug label records with OXYMETAZOLINE HCI 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 Sinus Max Clear and Cool Severe Congestion used for?
Uses ■ temporarily relieves nasal congestion due to: ■ a cold ■ hay fever or other upper respiratory allergies ■ promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure ■ helps clear nasal passages; shrinks swollen membranes

Who makes Mucinex Sinus Max Clear and Cool Severe Congestion?
Reckitt Benckiser LLC is the labeler of record for Mucinex Sinus Max Clear and Cool Severe Congestion. 2 FDA label records share the active ingredient OXYMETAZOLINE HCI, 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 Sinus Max Clear and Cool Severe Congestion come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Mucinex Sinus Max Clear and Cool Severe Congestion 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 OXYMETAZOLINE HCI?
Yes. 2 FDA drug label records list OXYMETAZOLINE HCI 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 Sinus Max Clear and Cool Severe Congestion 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.