FDA.reportPublic FDA data

Vicks ® Sinex™ Severe Original Nasal Spray

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:24:09

Label at a glance#

ProductVicks Sinex Severe Original
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

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

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.

SPL UNCLASSIFIED 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

  • 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

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

Oxymetazoline HCl Nasal Decongestant


ORIGNAL

NASAL SPRAY

  • Fast Sinus Congestion & Pressure Relief
  • Powerful Vicks Vapors

12
HOUR

½ FL OZ
(15 ml)

SSSSSS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-170-012021-02-12C16284748780-1ba0f9c33-56c1-a910-e053-dadaa90a0b85Vicks ® Sinex™ Severe Original Nasal Spray
37000-170-012021-01-29C16284748780-1ba0f9c33-56c1-a910-e053-dadaa90a0b85Vicks ® Sinex™ Severe Original Nasal Spray

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
37000-17037000-170-01

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
0abfbf1c-2743-a358-e063-6394a90a64b77d50b4d8-1f92-7898-e053-2a91aa0a241d2023-11-22WarningsExact identifier
spl set id: 7d50b4d8-1f92-7898-e053-2a91aa0a241d

Reported adverse events (FAERS/openFDA)#

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