Drugplain

SUDAFED OM Sinus Severe Original 50 mg/100mL

Oxymetazoline Hydrochloride · SPRAY · Kenvue Brands LLC

No Recall History
Plain English

SUDAFED OM Sinus Severe Original is a spray containing oxymetazoline hydrochloride at 50 mg/100mL, taken nasal. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
SUDAFED OM Sinus Severe Original
Generic Name
Oxymetazoline Hydrochloride
NDC Code (Product)
50580-787
Manufacturer
Kenvue Brands LLC
Strength
50 mg/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
09/04/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue46 reports
nausea43 reports
pain40 reports
diarrhoea37 reports
product dose omission issue34 reports
drug ineffective28 reports
headache27 reports
off label use27 reports
pruritus27 reports
cough25 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely

Dosage & Administration

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: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. 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 use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur 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 (1-800-222-1222).

Frequently Asked Questions

What is SUDAFED OM Sinus Severe Original used for?

SUDAFED OM Sinus Severe Original contains Oxymetazoline Hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is SUDAFED OM Sinus Severe Original a controlled substance?

SUDAFED OM Sinus Severe Original is not classified as a controlled substance by the DEA.

What is the generic name for SUDAFED OM Sinus Severe Original?

The generic name for SUDAFED OM Sinus Severe Original is Oxymetazoline Hydrochloride. There are 11 other brand versions of Oxymetazoline Hydrochloride.

What is the NDC code for SUDAFED OM Sinus Severe Original 50 mg/100mL?

The NDC (National Drug Code) for SUDAFED OM Sinus Severe Original 50 mg/100mL is 50580-787, listed by Kenvue Brands LLC.