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

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

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

Nasal Relief Spray

NASAL RELIEF  12-HOUR
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-5005
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
EDETATE DISODIUM 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
WATER 
SODIUM CHLORIDE 
SORBITOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5005-721 in 1 CARTON
115 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: bad09514-ea1b-4d6d-8489-8898136037ce
Set id: 078de5f2-6f0b-4f97-82cf-c0d150437291
Version: 3
Effective Time: 20130115
 
Rugby Laboratories