Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool

Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool is an FDA-registered drug product whose active ingredient is OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-216, application M012, label effective 20260513. It is one of 2 FDA drug label records sharing the active ingredient OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND 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 OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN 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 Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily reduces fever

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.Wipe nozzle clean after use. To close, turn cap clockwise. DO NOT DISCARD CAP. Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 capsules in any 24-hour period ■ adults and children 12 years of age and over: take 2 capsules every 4 hours ■ children under 12 years of age: do not use

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 Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 capsules in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

FDA lists 2 drug label records with OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND 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 Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool 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 Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm …

Who makes Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool?
Reckitt Benckiser LLC is the labeler of record for Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool. 2 FDA label records share the active ingredient OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND 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 Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool 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 Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool 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 HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN?
Yes. 2 FDA drug label records list OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND 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 Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool 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.