NASAL RELIEF 12-HOUR- oxymetazoline hydrochloride spray 
Rugby Laboratories

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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Oxymetazoline Hydrochloride
Nasal Decongestant 12-Hour Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

temporary relief of nasal congestion
due to the common cold
due to hay fever or other upper respiratory allergies
associated with sinusitis
temporarily restores freer breathing through the nose

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Do not use

for more than 3 days

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

When using this product

frequent or prolonged use may cause nasal congestion to recur or worsen
do not use more than directed
there may be temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
use only as directed as frequent or prolonged use may cause nasal congestion to recur or worsen
infection may spread if container is used by more than one person

Stop use and ask a doctor if

symptoms persist

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 to under 12 years of age (with adult supervision): 2 to 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 under 6 years of age: do not use
To spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), purified water, sodium chloride, sorbitol

Questions?

Call 1-866-645-2158

Distributed by:
Rugby Laboratories
Livonia, MI 48150  USA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Compare to the
active ingredient
in Afrin ®*

Nasal
Decongestant
12- Hour Spray

Oxymetazoline
Hydrochloride 0.05%

Maximum Strength

Fast Acting
Up To 12 Hours Relief
Nasal Relief Spray
NASAL RELIEF  12-HOUR
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5005
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)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5005-721 in 1 CARTON10/29/201210/31/2017
115 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 finalpart34110/29/201210/31/2017
Labeler - Rugby Laboratories (079246066)

Revised: 9/2019
 
Rugby Laboratories