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Nasal by A-S Medication Solutions

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 5g in 100mL
Labeler: A-S Medication Solutions
NDC Code: 50090-0335

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.

MAJOR®
Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

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
  • temporarily relieves sinus congestion and pressure
  • 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 use more than directed
  • do not use for more than 3 days. Use only as directed.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • 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 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 often than every 10 to 12 hours
  • do not exceed 2 doses within any 24-hour period
  • children under 6 years of age: consult a doctor

Before using the first time, remove the protective cap from the tip. To spray, hold bottle between the thumb and first and second fingers. Without tilting head, insert nozzle into nostril. Squeeze the bottle quickly and firmly. Wipe nozzle clean after use.

Other information

  • store between 20° to 25° C (68° to 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?

To Report Adverse Drug Event Call: (800) 616-2471

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, Ml 48152 USA

HOW SUPPLIED

Product: 50090-0335

NDC: 50090-0335-0 15 mL in a BOTTLE, SPRAY

Oxymetazoline Hydrochloride
NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0335(NDC:0904-5711)
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Benzalkonium Chloride 
Edetate Disodium 
Propylene Glycol 
Benzyl Alcohol 
Sodium Phosphate, Dibasic, Unspecified Form 
Sodium Phosphate, Monobasic, Unspecified Form 
Povidone, Unspecified 
Hydrochloric Acid 
Polyethylene Glycol 1450 
Packaging
#Item CodePackage Description
1NDC:50090-0335-0 15 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/2009
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0335)

Revised: 10/2017
 
A-S Medication Solutions

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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