ULTRA FINE MIST SINUS RELIEF- oxymetazoline hydrochloride spray 
DOLGENCORP, INC.

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.

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Dollar General Severe Nasal Spray Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

temporarily relieves

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

Warnings

Ask a doctor before use if you have

heart disease
high blood pressure
diabetes
thyroid disease
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 at (1-800-222-1222).

Directions

adults & children 6 to under 12 years of age & 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 any 24-hour period.
children 2 to under 6 years: ask a doctor
children 2 years: do not use

To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim.Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Other information

store at room temperature

Inactive ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC# 55910-627-30

Compare to the active ingredient in Vicks® Sinex™ Severe Original*

ULTRA FINE MIST

SINUS RELIEF

Oxymetazoline HCl

Nasal Decongestant

Original

Fast Sinus Congestion & Pressure Relief

12 Hour

Pump Mist

1 FL OZ (30 mL)

IMPORTANT: Keep the carton for future reference on full labeling

Distributed by:

*This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original

Ultra Fine Mist Sinus Relief
ULTRA FINE MIST  SINUS RELIEF
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-627
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
Product Characteristics
ColorWHITE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-627-301 in 1 CARTON09/18/2020
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/18/2020
Labeler - DOLGENCORP, INC. (068331990)

Revised: 9/2023
Document Id: 771d4e1d-2424-4288-a0ff-9d854766a76b
Set id: 5f134840-2465-4585-a85d-08d746f76f7a
Version: 4
Effective Time: 20230915
 
DOLGENCORP, INC.