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topcare sinus severe

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE .05g in 100mL
Labeler: Topco Associates LLC
NDC Code: 36800-607

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Topco Associates LLC. Sinus Severe Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

nasal congestion due to a cold, hay fever, or other upper respiratory allergies
sinus congestion and pressure

Warnings

Ask a doctor before use if you have
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland

When using this product
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
symptoms persist

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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
store at 20-25°C (68-77°F)

Inactive ingredients

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?

1-888-423-0139

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)

TOPCARE SINUS SEVERE 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-607
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, DIBASIC 
EDETATE DISODIUM 
EUCALYPTOL 
MENTHOL, UNSPECIFIED FORM 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
ColorWHITE (off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-607-101 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/06/2017
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

Medically reviewed on Nov 14, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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