Drugplain

Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST .0005095 g/mL

Oxymetazoline Hydrochloride · SPRAY · Procter & Gamble Manufacturing GmbH

No Recall History
Plain English

Vicks Sinex Severe Vapocool Ultra Fine Mist is a nasal spray containing oxymetazoline that helps relieve severe nasal congestion from colds, allergies, or sinus problems. This over-the-counter decongestant works by narrowing blood vessels in the nasal passages to reduce swelling and improve breathing.

Key Facts

Brand Name
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST
Generic Name
Oxymetazoline Hydrochloride
NDC Code (Product)
64336-173
Manufacturer
Procter & Gamble Manufacturing GmbH
Strength
.0005095 g/mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
05/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue47 reports
nausea44 reports
pain41 reports
diarrhoea37 reports
product dose omission issue34 reports
drug ineffective28 reports
headache28 reports
off label use28 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 a cold, hay fever, or other upper respiratory allergies sinus congestion and pressure

Dosage & Administration

Directions Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, inset nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. adults & children 6 yrs. & older (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 24 hours. children 2 to under 6 yrs. ask a doctor children under 2 yrs. do not use

Warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to 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 temporary discomfort such as burning, stinging, sneezing, or increased 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

Frequently Asked Questions

What is Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST used for?

Vicks Sinex Severe Vapocool Ultra Fine Mist is a nasal spray containing oxymetazoline that helps relieve severe nasal congestion from colds, allergies, or sinus problems. This over-the-counter decongestant works by narrowing blood vessels in the nasal passages to reduce swelling and improve breathing.

Is Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST a controlled substance?

Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST is not classified as a controlled substance by the DEA.

What is the generic name for Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST?

The generic name for Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST is Oxymetazoline Hydrochloride. There are 12 other brand versions of Oxymetazoline Hydrochloride.

What is the NDC code for Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST .0005095 g/mL?

The NDC (National Drug Code) for Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST .0005095 g/mL is 64336-173, listed by Procter & Gamble Manufacturing GmbH.

Product NDC

64336-173

Package NDC

64336-173-01

Other Oxymetazoline Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)