FDA.reportPublic FDA data

Vicks Sinex Severe VapoCOOL Ultra Fine Mist 12 Hour spray

Manufacturer
Procter & Gamble Manufacturing GmbH
Effective date
2021-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:28:17

Label at a glance#

ProductVicks Sinex Severe VapoCOOL Ultra Fine Mist 12 Hour
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies sinus congestion and pressure

Dosage and administration

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 tha...

Storage and handling

do not exceed 25ºC

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms persist.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • do not exceed 25ºC

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate

Questions?

OTC - QUESTIONS SECTION

1-800-873-8276

SPL UNCLASSIFIED SECTION

MADE IN GERMANY
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

Sinex™

SEVERE

Oxymetazoline HCl: Nasal Decongestant

ULTRA FINE MIST

CLEARS NASAL CONGESTION FAST!

VapoCOOL

½ FL OZ

(15 ml)

6433617364336173

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64336-40064336-400-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ef537234-1993-1aae-e053-2a95a90a230dd09d0803-dbcf-659c-e053-2a95a90a9e6a2022-12-08WarningsExact identifier
spl set id: d09d0803-dbcf-659c-e053-2a95a90a9e6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.