Major Nasal Decongestant Spray

Major Nasal Decongestant Spray
SPL v2
SPL
SPL Set ID edb49b17-06a7-4c25-bc7c-d62c1deac7f1
Route
NASAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Polyethylene Glycol 300 Glycerin Propylene Glycol Edetate Disodium Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic, Anhydrous Povidone Benzalkonium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-31
Description

Oxymetazoline HCL 0.05%

Purpose

Nasal Decongestant

Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline HCL 0.05%

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 53414-9

ask a health professional before use.

Purpose 

Nasal Decongestant

Warnings 

Directions 
  • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
Active Ingredient 

Oxymetazoline HCL 0.05%

Other Information 
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients 

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal Display Panel 

Major© Original Nasal Spray NDC 0904-7435-35

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist Nasal Decongestant

1/2 FLOZ (15ML)

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

Keep Out of the Reach of Children

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

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

Structured Label Content

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 53414-9 (53414-9)

ask a health professional before use.

Purpose 

Nasal Decongestant

Warnings 

Directions 
  • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
Active Ingredient 

Oxymetazoline HCL 0.05%

Other Information  (Other information )
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients  (Inactive ingredients )

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal Display Panel 

Major© Original Nasal Spray NDC 0904-7435-35

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist Nasal Decongestant

1/2 FLOZ (15ML)

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

Symptoms persist

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

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:37.341478 · Updated: 2026-03-14T23:02:16.200124