Your browser does not support JavaScript! NASAL RELIEF 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [RUGBY LABORATORIES]
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NASAL RELIEF 12-HOUR (oxymetazoline hydrochloride) spray
[Rugby Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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 Description
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: 01/2013
Document Id: bad09514-ea1b-4d6d-8489-8898136037ce
Set id: 078de5f2-6f0b-4f97-82cf-c0d150437291
Version: 3
Effective Time: 20130115
 
Rugby Laboratories

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