OTC Medication Information: Nasal

NASAL- oxymetazoline hydrochloride spray
Preferred Pharmaceuticals, Inc.

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.

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

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 use more than directed
2.
do not use for more than 3 days. Use only as directed.
3.
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
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

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.

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

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

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.

Nasal Decongestant 12-Hour Spray
(click image for full-size original)
NASAL
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9155(NDC:0904-5711)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9155-3 30 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/17/2009
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-9155)

Revised: 07/2020 Preferred Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.