MUCINEX Rapid Clear Day Night and Clear and Cool Nasal

MUCINEX Rapid Clear Day Night and Clear and Cool Nasal is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE. It is labelled by Reckitt Benckiser LLC and marketed as a human otc drug product. Identifiers on file: NDC 72854-213, application M012, label effective 20260513. 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 ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, sore throat, reduces fever, pains headache, helps loosen. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

DAY 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 NIGHT Uses ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep SPRAY Uses temporarily relieves nasal congestion due to: a cold hay fever or other upper respiratory allergies promotes nasal and sinus drainage temporarily relieves sinus congestion and pressure helps clear nasal passages; shrinks swollen membranes

DAY Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 12 caplets in any 24-hour period ■ adults and children 12 years of age and over: take 2 caplets every 4 hours ■ children under 12 years of age: do not use NIGHT Directions ■ do not take more than directed (see Overdose warning) ■ do not take more than 8 caplets in any 24-hour period ■ adults and children 12 years of age and over: take 2 caplets every 4 hours ■ children under 12 years of age: do not use SPRAY 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.

DAY Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 12 caplets 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. Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. NIGHT Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 caplets 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. ■ 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 ■ liver disease ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving amotor vehicle or operatingmachinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. SPRAY 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 ifsymptoms persist If pregnant or breast-feeding,ask a health professional before use.

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 Day Night and Clear and Cool Nasal used for?
DAY 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 NIGHT Uses ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore …

Who makes MUCINEX Rapid Clear Day Night and Clear and Cool Nasal?
Reckitt Benckiser LLC is the labeler of record for MUCINEX Rapid Clear Day Night and Clear and Cool Nasal.

Is MUCINEX Rapid Clear Day Night and Clear and Cool Nasal 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.

Has MUCINEX Rapid Clear Day Night and Clear and Cool Nasal 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.