topcare sinus severe

Manufacturer
Topco Associates LLC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:55:56

Label at a glance#

Producttopcare sinus severe
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 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 nos...

Label contents#

Full prescribing information#

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an 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 an increase in 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)

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 or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WITH MENTHOL

Sinus Severe

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12 Hour Relief

Ultra Fine Mist

Sinus congestion & pressure

Fast & powerful relief

QUALITY GUARANTEED

COMPARE TO SINEX® SEVERE active ingredient

1 FL OZ (30 mL)

7x0-88-sinus severe.jpg
7x0-88-sinus severe.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-60736800-607-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
440ce25c-3e7f-4c45-862f-c4537a8d613ef342cc57-4fdd-4c0a-bc83-b7908741a7432020-12-16WarningsExact identifier
spl set id: f342cc57-4fdd-4c0a-bc83-b7908741a743

Reported adverse events (FAERS/openFDA)#

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