Indications and uses
for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen membranes so you can breathe more freely
MAJOR ® Soothing - 12 Hour NASAL DECONGESTANT Spray
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2017-10-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:09:59
Label at a glance#
ProductNasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
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 Before using the first time, remove the protective cap from the tip. To spray, hold bottle between the thumb and first and second fingers. Without tilting head, insert nozzle in...
Storage and handling
store between 20° to 25° C (68° to 77° F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
- temporarily relieves sinus congestion and pressure
- shrinks swollen membranes so you can breathe more freely
Warnings
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed.
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- 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
OTC - STOP USE SECTION
Stop use and ask doctor if symptoms persist.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
Before using the first time, remove the protective cap from the tip. To spray, hold bottle between the thumb and first and second fingers. Without tilting head, insert nozzle into nostril. Squeeze the bottle quickly and firmly. Wipe nozzle clean after use.
STORAGE AND HANDLING SECTION
- 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
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, Ml 48152 USA
HOW SUPPLIED
Product: 50090-0335
NDC: 50090-0335-0 15 mL in a BOTTLE, SPRAY
Oxymetazoline Hydrochloride
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0335-0 | ML - Milliliter | 50090-0335 | 2b6ceff3-8628-4dd7-8367-2b1af3373783 | 1 | 2018-09-05 |
| 0904-5711-30 | ML - Milliliter | 0904-5711 | 5f70d9ad-76e0-4189-9c3f-13968c268b45 | 1 | 2012-07-24 |
| 0904-5711-35 | ML - Milliliter | 0904-5711 | 1e9c80cd-6892-4c20-b4b4-f917747bba53 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Nasal
- Oxymetazoline Hydrochloride
- OXYMETAZOLINE
- Water
- Benzalkonium Chloride
- Edetate Disodium
- Propylene Glycol
- Benzyl Alcohol
- Sodium Phosphate, Dibasic, Unspecified Form
- Sodium Phosphate, Monobasic, Unspecified Form
- Povidone, Unspecified
- Hydrochloric Acid
- Polyethylene Glycol 1450
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-0335 | 50090-0335-0 |
| 0904-5711 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5bb972af-58c2-4c34-bc0c-e386f2ce4ac3 | 7c09eb4a-612d-4207-b6c4-6cae8be0e10c | 2017-10-02 | Warnings | 5bb972af-58c2-4c34-bc0c-e386f2ce4ac3 7c09eb4a-612d-4207-b6c4-6cae8be0e10c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.