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Nasal by Proficient Rx LP

Medically reviewed on May 2, 2018

Dosage form: spray
Ingredients: Oxymetazoline Hydrochloride 5g in 100mL
Labeler: Proficient Rx LP
NDC Code: 63187-701

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 0904-5711-35

MAJOR®

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)

NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-701(NDC:0904-5711)
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Benzalkonium Chloride 
Edetate Disodium 
Propylene Glycol 
Benzyl Alcohol 
Sodium Phosphate, Dibasic 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
POVIDONES 
Hydrochloric Acid 
Polyethylene Glycol 1450 
Packaging
#Item CodePackage Description
1NDC:63187-701-1515 mL in 1 BOTTLE, SPRAY
2NDC:63187-701-3030 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2009
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-701)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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