NASAL- oxymetazoline hydrochloride spray 
Major Pharmaceuticals

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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MAJOR®
Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

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 3 days. 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 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 quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Other information

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

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NDC 0904-5711-35

MAJOR®

Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

REGULAR

oxymetazoline
hydrochloride
0.05%

RELIEVES
CONGESTION
FAST

Compare to
active ingredient
of Afrin®

1/2 FL.OZ.
(15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Carton
NASAL 
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5711
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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)  
Povidone (UNII: FZ989GH94E)  
Hydrochloric Acid (UNII: QTT17582CB)  
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5711-35 30 mL in 1 BOTTLE, SPRAY
2 NDC:0904-5711-30 15 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/17/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 2/2011
Document Id: 3115ce25-2134-42fe-8d38-f2d57a31f5e0
Set id: 61e9dd22-7e7b-460f-80f6-a735667c6362
Version: 1
Effective Time: 20110216
 
Major Pharmaceuticals