MAJOR ® Soothing - 12 Hour NASAL DECONGESTANT Spray

Manufacturer: Preferred Pharmaceuticals, Inc.
Effective date: 2020-07-30
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 23:19:48

Label at a glance#

ProductNasal

Active ingredientOxymetazoline Hydrochloride

Label structure11 sections

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

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 noz...

Storage and handling

• store between 20° to 25° C (68° to 77° F)

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

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

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-9155-3

MAJOR^®

Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

REGULAR

oxymetazoline
hydrochloride
0.05%

RELIEVES
CONGESTION
FAST

Compare to
active ingredient
of Afrin®*

1/2 FL.OZ.
(15 mL)

Relabeled By: Preferred Pharmaceuticals Inc.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Oxymetazoline Hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	2
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	2
Polyethylene Glycol 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	2
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

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 table
Product NDC	Package NDC
68788-9155	68788-9155-3
0904-5711

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Oxymetazoline Hydrochloride	K89MJ0S5VY	ACTIB
Water	059QF0KO0R	IACT
Benzalkonium Chloride	F5UM2KM3W7	IACT
Edetate Disodium	7FLD91C86K	IACT
Propylene Glycol	6DC9Q167V3	IACT
Benzyl Alcohol	LKG8494WBH	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	3980JIH2SW	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
Hydrochloric Acid	QTT17582CB	IACT
Polyethylene Glycol 1450	OJ4Z5Z32L4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 441 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Polyethylene Glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	TABLET, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	TABLET, EXTENDED RELEASE / ORAL		143 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	CONCENTRATE / ORAL	2.17 mg/1ml		Exact identifier — unii candidate 148 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAMUSCULAR		306 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SOLUTION / ORAL	40 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SPRAY / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PERIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVESICAL		157 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRAVENOUS	18.25 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 148 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-ARTERIAL		840 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Hydrochloric Acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
36423d9c-279b-4976-ad13-b7f2e41f5de4			c49835ea-8850-4bae-8968-398ad4cb7980	2021-08-05	Warnings	Exact identifier spl set id: c49835ea-8850-4bae-8968-398ad4cb7980

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.