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Nasal Decongestant by Promex, LLC

Medically reviewed on Dec 11, 2017

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: Promex, LLC
NDC Code: 58988-0193

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.

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Warnings

Do not use this product 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

When using this product
  • do not exceed recommended dosage
  • use only as directed. frequent of 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.

Directions

  • To spray, squeeze bottle qiuckly and firmly
  • Do not tilt head backward while spraying
  • Wipe nozzle clean after use
  • Do not exceed 2 doses in any 24 hour period
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
  • chlidren under 6 years of age: ask a doctor

Other information

  • store at room temperature 15 - 30°C (59-86°F)
  • retain carton for future reference on full labeling
  • SAFETY SEAL: Do not use if seal on bottle is broken or missing

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Carton image

NASAL DECONGESTANT 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0193
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 
BENZYL ALCOHOL 
EDETATE DISODIUM 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
Water 
Packaging
#Item CodePackage Description
1NDC:58988-0193-51 BOTTLE (BOTTLE) in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/09/2013
Labeler - Promex, LLC (789974388)

 
Promex, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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