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Name:Nasal
Manufacturer:Major Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


MAJOR® Soothing - 12 Hour NASAL DECONGESTANT Spray

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

  • 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 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

  • 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

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° 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

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 (Oxymetazoline) Oxymetazoline Hydrochloride 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Benzalkonium Chloride  
Edetate Disodium  
Propylene Glycol  
Benzyl Alcohol  
Sodium Phosphate, Dibasic  
Sodium Phosphate, Monobasic  
Povidone  
Hydrochloric Acid  
Polyethylene Glycol 1450  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-5711-35 30 mL in 1 BOTTLE, SPRAY None
2 NDC:0904-5711-30 15 mL in 1 BOTTLE, SPRAY None

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: 02/2011 Major Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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