Major Original Nasal Decongestant Spray Drug Facts

Major Original Nasal Decongestant Spray Drug Facts
SPL v8
SPL
SPL Set ID 35fbf78f-8420-4282-8922-1814268ee570
Route
NASAL
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Edetate Disodium Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-05-16 Until 2026-03-31

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline hydrochloride 0.05%

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
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.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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, owner of the registered trademark Afrin ®Original.

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).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

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
Purpose

Nasal Decongestant

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.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature
  • Keep this carton for future reference on full labeling.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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, owner of the registered trademark Afrin ®Original.

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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