Theraflu Severe Congestion Relief Cooling Nasal Mist

Theraflu Severe Congestion Relief Cooling Nasal Mist is an FDA-registered drug product whose active ingredient is OXYMETAZOLINE HCL. It is labelled by Haleon US Holdings LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 0067-0109, application M012, label effective 20260608. It is one of 4 FDA drug label records sharing the active ingredient OXYMETAZOLINE HCL. 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 HCL are most often described in connection with: temporarily relieves, nose helps, nasal decongestion, due common, cold hay, upper respiratory, allergies allergic, passages shrinks. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves nasal decongestion due to: common cold hay fever or other upper respiratory allergies (allergic rhinitis) temporarily relieves stuffy nose helps clear nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Directions do not use more than directed adults and children 6 years to under 12 years of age (with adult supervision): 2 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 To Use: To remove the cap, press grooves on each side and turn to lift cap. Before using the first time, prime the sprayer by pressing the button until a spray comes out of the sprayer tip. To use, insert sprayer tip into nostril, firmly press the button with thumb and sniff deeply. Stay upright while spraying. Wipe sprayer tip clean and secure cap after use.

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged 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. If symptoms persist, consult a doctor. temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur the use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

FDA lists 4 drug label records with OXYMETAZOLINE HCL 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 Theraflu Severe Congestion Relief Cooling Nasal Mist used for?
Uses temporarily relieves nasal decongestion due to: common cold hay fever or other upper respiratory allergies (allergic rhinitis) temporarily relieves stuffy nose helps clear nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Who makes Theraflu Severe Congestion Relief Cooling Nasal Mist?
Haleon US Holdings LLC is the labeler of record for Theraflu Severe Congestion Relief Cooling Nasal Mist. 4 FDA label records share the active ingredient OXYMETAZOLINE HCL, 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 Theraflu Severe Congestion Relief Cooling Nasal Mist 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 Theraflu Severe Congestion Relief Cooling Nasal Mist 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 HCL?
Yes. 4 FDA drug label records list OXYMETAZOLINE HCL 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 Theraflu Severe Congestion Relief Cooling Nasal Mist 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.