Mucinex DS 12HR COLD, FEVER and SINUS

Mucinex DS 12HR COLD, FEVER and SINUS is an FDA-registered drug product whose active ingredient is NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-223, application ANDA076518, label effective 20260512. 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 NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, cold sinus, flu symptoms, pressure minor, body aches, pains headache, congestion promotes, restores freer. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these cold, sinus, and flu symptoms: ■ sinus pressure ■ minor body aches and pains ■ headache ■ nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) ■ fever

Directions ■ do not take more than directed ■ the smallest effective dose should be used ■ swallow whole ; do not crush or chew ■ drink a full glass of water with each dose ■ adults and children 12 years and older: 1 extended-release tablet every 12 hours ; do not take more than 2 extended-release tablets in 24 hours ■ children under 12 years: do not use

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 DS 12HR COLD, FEVER and SINUS used for?
Uses temporarily relieves these cold, sinus, and flu symptoms: ■ sinus pressure ■ minor body aches and pains ■ headache ■ nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) ■ fever

Who makes Mucinex DS 12HR COLD, FEVER and SINUS?
Reckitt Benckiser LLC is the labeler of record for Mucinex DS 12HR COLD, FEVER and SINUS.

What form does Mucinex DS 12HR COLD, FEVER and SINUS 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 DS 12HR COLD, FEVER and SINUS 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 DS 12HR COLD, FEVER and SINUS 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.