MAJOR NASAL DECONGESTANT- oxymetazoline hydrochloride spray

Major Nasal Decongestant by

Drug Labeling and Warnings

Major Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts 

Active Ingredient 

Oxymetazoline 0.05%

Purpose 

Nasal Decongestant

Uses

Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiroty 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 diease
• high blood pressure
• diabetes
• thyiod diease
• trouble urinating due to enlarged rostate gland.

When using this product 

Do not use more than directed

• do not use for more than three days, Use only as directed. Frequent or 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 the reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions 

• Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
• Wipe nozzle clean after use.
• 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 in any 24-hour period.
• Children under 6 years of age consult a doctor.

Other information 

• store between 20° - 25°C (68° to 77°F)
• retain carton for future reference on full labeling

Inactive ingredients 

Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Questions? Call 800-222-1807

Principal Display Panel 

Major ® No Drip Nasal Mist NDC: 68788-8744-3
Nasal Spray Oxymetazoline HCL 0.05%
12 hour Nasal Spray
1 FL OZ (30 mL)

Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

MAJOR NASAL DECONGESTANT 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-8744(NDC:0904-7427)
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8744-3	1 in 1 CARTON	09/26/2024
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/26/2024

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-8744)