MAJOR- nasal decongestant spray

Major by

Drug Labeling and Warnings

Major by is a Otc medication manufactured, distributed, or labeled by MAJOR PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

• ▪ temporarily relief of nasal congestion due to the
• ▪ common cold
• ▪ hay fever
• ▪ other upper respiratory allergies
• ▪ temporarily relieves sinus congestion and pressure
• ▪ shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• ▪ heart disease
• ▪ high blood pressure
• ▪ diabetes
• ▪ thyroid disease
• ▪ trouble urinating due to an 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. 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 reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

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 in any 24-hour period.
• ▪ children under 6 years of age: ask a doctor

To use: Push firmly down on cap and turn counter clockwise.

To Spray: Squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Other information

• ▪ store at room temperature
• ▪ Keep this carton for future reference on full labeling.

Inactive ingredients

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

Questions or comments?

1-866-467-2748

Principal Display Panel

MAJOR®

Compare to the active ingredient in Afrin® Original*

NDC# 0904-7006-35

Nasal Decongestant Spray

OXYMETAZOLINE HCL 0.05%

Original

Fast, Powerful Congestion Relief

For Colds & Allergies

Up to 12 Hour Relief

12 Hour Relief

Maximum Strength

NASAL DECONGESTANT

12 HOUR

1/2 FL OZ (15 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

This product starts to work in seconds providing up to 12 hours of nasal congestion relief without drowsiness.

Up to 12-hour relief from nasal congestion, Relief lasts All-Day or All-Night.

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributer of Afrin® No Drip Original.

INGREDIENTS AND APPEARANCE

MAJOR 
nasal decongestant spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7006
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7006-35	1 in 1 CARTON	05/16/2019
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/16/2019

Labeler - MAJOR PHARMACEUTICALS (191427277)