NASAL RELIEF- 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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Nasal Relief

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

  • For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland

When using this product

  • do not exceed recommended dosage
  • do not use for more than 3days. Use only as directed
  • 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
  • frequent or prolonged use may cause nasal congestion to recur or worsen

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.

Directions

  • adults and children 6 to under 12 years of age (with adult supervision) 2 or 3 sprays in each nostril not more than every 10 to 12 hours
  • do not exceed 2 doses within any 24 hour period
  • children under 5 years of age, consult a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

  • store between 20° to 25° C (68°-77° F)

Inactive ingredients

Benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

COMPARE TO
ACTIVE INGREDIENT IN
AFRIN®*

NDC 0536-1013-94

Rugby®

NASAL RELIEF
SPRAY

NRS®

Oxymetazoline Hydrochloride 0.05%

up to
12
HOUR
RELIEF

Long-Acting
Nasal Decongestant

1/2 fl oz (15 mL)

Principal Display Panel - 15 mL Bottle Carton
NASAL RELIEF 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1013
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium (UNII: 7FLD91C86K)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
Povidones (UNII: FZ989GH94E)  
Hydrochloric Acid (UNII: QTT17582CB)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1013-941 in 1 CARTON07/14/201411/30/2016
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 FINALpart34107/14/201411/30/2016
Labeler - Rugby Laboratories (079246066)
Registrant - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(0536-1013) , ANALYSIS(0536-1013) , PACK(0536-1013) , LABEL(0536-1013)

Revised: 8/2018
Document Id: 101aa9c3-5cab-4044-acf0-458571b9f441
Set id: eb6cd7b6-f9d7-4265-949b-4c44e4f137e6
Version: 2
Effective Time: 20180824
 
Rugby Laboratories