FDA.reportPublic FDA data

Vicks ® Sinex™ SEVERE CONGESTION, NASAL SPRAY

Manufacturer
Procter & Gamble Manufacturing GmbH
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-06 02:02:24

Label at a glance#

ProductVicks Sinex SEVERE CONGESTION
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure17 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

adults & children 6 years & 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 years ask a doctor children under 2 years do not use

Storage and handling

store at no greater than 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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • symptoms persist

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults & children 6 years & 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 yearsask a doctor
children under 2 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at no greater than 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

Note: This container is properly filled when approximately half full. Air space equal to one half of volume is necessary to propel the fine spray.

Only selected information is listed on the bottle label. Keep this container for future reference.

TAMPER EVIDENT: CARTON SEALED FOR YOUR PROTECTION.

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 CONGESTION

Oxymetazoline HCl Nasal Decongestant


NASAL SPRAY

  • Fast Relief for Sinus, Allergy & Nasal Congestion
  • Sinus Pressure

12 HOUR RELIEF

0.5 FL OZ
(15 ml)

002002

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130323900012523GTIN-13: 0323900012523
EAN-13: 0323900012523
GTIN-12: 323900012523
UPC-A: 323900012523
GTIN storage (14 digits): 00323900012523		002.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

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
64336-00264336-002-01

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
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-18full-release2026-06-01 01:47:42

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
Vicks Sinex SEVERE CONGESTIONOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH4644c4ae-9607-d404-e063-6294a90aca242025-12-18WarningsExact identifier
ndc (package): 64336-002-01
ndc (product): 64336-002
ndc11 (package): 64336000201
spl set id: 4644c4ae-9607-d404-e063-6294a90aca24

Reported adverse events (FAERS/openFDA)#

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