FDA.reportPublic FDA data

Severe Sinus Relief Mist

Manufacturer
Walgreens
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:40:31

Label at a glance#

ProductSevere Sinus Relief Mist
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Tempoarily relieves nasal congestion due to: common cold hay fever upper respiroty allergies temporaily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely

Dosage and administration

aduts and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: ask a doctor To use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly severa...

Label contents#

Full prescribing information#

Drug facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline Hydrochloride 0.05%

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

OTC - WHEN USING SECTION

  • Do not use more than directed
  • do not use for more than three 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 an increase in nasal discharge may occur.
  • use of this container by more than one person may spread infection.

Stop use and as a doctor

OTC - STOP USE SECTION

symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • aduts and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age: ask a doctor

To use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle wth thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Secure cap after use.

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Questions or comments

OTC - QUESTIONS SECTION

1-800-925-4733

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Polysorbate 80, Sorbitol Solution 70%, Edetate Disodium USP, Citric Acid Anhydrous Powder, Sodium Citrate anhydrous, Benzyl Alcohol, Benzalkonium Chloride 50%

PRINCIPAL PANEL 0.5 FLOZ BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

PRINCIPAL DISPLAY PANEL -CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

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
0363-70090363-7009-15

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
WATER059QF0KO0RIACT
ANHYDROUS TRISODIUM CITRATERS7A450LGAIACT
EDETATE DISODIUM7FLD91C86KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYSORBATE 806OZP39ZG8HIACT
BENZYL ALCOHOLLKG8494WBHIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT

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
0905369d-99b5-26e7-e063-6294a90aa571b6fb4ef1-4d2d-f03f-e053-2995a90a8ef62023-10-31WarningsExact identifier
spl set id: b6fb4ef1-4d2d-f03f-e053-2995a90a8ef6

Reported adverse events (FAERS/openFDA)#

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