Drugplain

Theraflu Severe Congestion Relief Nasal Mist .5 mg/mL

Oxymetazoline HCl · SPRAY · Haleon US Holdings LLC

No Recall History
Plain English

Theraflu Severe Congestion Relief Nasal Mist is a spray containing oxymetazoline hcl at .5 mg/mL, taken nasal. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Theraflu Severe Congestion Relief Nasal Mist
Generic Name
Oxymetazoline HCl
NDC Code (Product)
0067-0110
Manufacturer
Haleon US Holdings LLC
Strength
.5 mg/mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
06/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

anosmia29 reports
ageusia23 reports
drug ineffective14 reports
dizziness12 reports
anxiety11 reports
dyspnoea11 reports
headache11 reports
diarrhoea10 reports
feeling abnormal10 reports
vomiting10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves nasal decongestion due to: o common cold o 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

Dosage & Administration

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: Shake well before 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 several times. To spray, 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

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.

Frequently Asked Questions

What is Theraflu Severe Congestion Relief Nasal Mist used for?

Theraflu Severe Congestion Relief Nasal Mist contains Oxymetazoline HCl. It is a spray taken nasal. Consult your doctor for specific uses.

Is Theraflu Severe Congestion Relief Nasal Mist a controlled substance?

Theraflu Severe Congestion Relief Nasal Mist is not classified as a controlled substance by the DEA.

What is the generic name for Theraflu Severe Congestion Relief Nasal Mist?

The generic name for Theraflu Severe Congestion Relief Nasal Mist is Oxymetazoline HCl. There are 11 other brand versions of Oxymetazoline HCl.

What is the NDC code for Theraflu Severe Congestion Relief Nasal Mist .5 mg/mL?

The NDC (National Drug Code) for Theraflu Severe Congestion Relief Nasal Mist .5 mg/mL is 0067-0110, listed by Haleon US Holdings LLC.