NASAL- oxymetazoline hydrochloride spray 
Proficient Rx LP

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MAJOR®
Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

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
•
shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to enlarged prostate gland

When using this product

1.
do not exceed recommended dosage
2.
do not use for more than 3 days. Use only as directed.
3.
may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
4.
the use of this container by more than one person may spread infection
5.
frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask 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.

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

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Other information

•
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

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NDC 63187-701-15

Relabeled by:

Proficient Rx LP, Thousand Oaks, CA 91320

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)

63187-701-15
NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-701(NDC:0904-5711)
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium (UNII: 7FLD91C86K)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Benzyl Alcohol (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Hydrochloric Acid (UNII: QTT17582CB)  
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-701-1515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/201601/31/2021
2NDC:63187-701-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/17/200901/31/2021
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(63187-701)

Revised: 10/2024
Document Id: 3fb37d46-4ebb-466a-ac0f-221ab4bdeec3
Set id: d9c10cc7-1a5c-43f2-87a8-5390a88d448a
Version: 4
Effective Time: 20241001
 
Proficient Rx LP