FDA.reportPublic FDA data

Vicks ® Sinex™ Severe No Drip Nasal Spray

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:53

Label at a glance#

ProductVicks Sinex Severe No Drip
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

Shake well before use. 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, insert 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 nost...

Storage and handling

do not exceed 25C

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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.

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

Shake well before use. 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, insert 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 25C

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

1-800-873-8276

SPL UNCLASSIFIED SECTION

DIST.BYPROCTER&GAMBLE,
CINCINNATIOH45202

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

Sinex™

SEVERE

Oxymetazoline HCl | Nasal Decongestant

NO DRIP

NASAL SPRAY

  • Fast Sinus Congestion & Pressure Relief
  • Powerful Vicks Vapors

12
HOUR

½ FL OZ (15 ml)

SSNDSSND

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-527-012021-02-11C16284748780-1ba0f9c33-5615-a910-e053-dadaa90a0b85Vicks ® Sinex™ Severe No Drip Nasal Spray
37000-527-012021-01-29C16284748780-1ba0f9c33-5615-a910-e053-dadaa90a0b85Vicks ® Sinex™ Severe No Drip Nasal Spray

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-52737000-527-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
EUCALYPTOLRV6J6604TKIACT
MENTHOLL7T10EIP3AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
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
051bf195-0aa1-c17f-e063-6394a90a81ea6f2b46cd-59c5-4196-e053-2991aa0a61cb2023-09-11WarningsExact identifier
spl set id: 6f2b46cd-59c5-4196-e053-2991aa0a61cb

Reported adverse events (FAERS/openFDA)#

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