12 HOUR NASAL- oxymetazoline hydrochloride spray
Altaire 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.

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12 Hour Nasal Spray

12 HOUR NASAL SPRAY

Oxymetazoline Hydrochloride 0.05% Nasal Spray

Drug Facts

Active ingredients

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

● temporarily relieves nasal congestion due to:

● common cold

● hay fever

● other respiratory allergies

● temporarily relieves sinus congestion and pressure

● shrinks swollen nasal membranes so you can breathe more freely

Warnings

● heart disease

● high blood pressure

● diabetes

● thyroid disease

● trouble urinating due to an enlarged prostate gland

When using this product

● do not use more than directed

● do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen

● Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur

● use of this container by more than one person may spread infection

Stop use and ask a 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 adults supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

● children under 6 years of age: ask a doctor

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

Other information

● store between 20° to 30°C (36° to 86°F)

● retain carton for future reference on full labeling

● see bottle or box for Lot Number and Expiration Date

Inactive ingredients

Benzalkonium chloride, disodium edetate, disodium phosphate, monosodium phosphate, purified water, sodium chloride, sorbitol

Questions or comments?

Call (631) 722-5988 9am-5pm EST Monday-Friday.

Tamper evident

Do not use if imprinted seal of bottle cap is torn, missing or broken.

Manufactured by

Altaire Pharmaceuticals, Inc. Aquebogue, NY

PRINCIPAL DISPLAY PANEL

NDC 59390-036-13
12 hour nasal spray
Oxymetazoline Hydrochloride 0.05%
½ fl oz (15 mL)

PRINCIPAL DISPLAY PANEL
NDC 59390-036-13
12 hour nasal spray
Oxymetazoline Hydrochloride 0.05%
½ fl oz (15 mL)

12 HOUR NASAL
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59390-036
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59390-036-13	1 in 1 CARTON	06/01/2001	02/21/2014
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	06/01/2001	02/21/2014

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Name	Address	ID/FEI	Business Operations
Establishment
Altaire Pharmaceuticals, Inc.		786790378	MANUFACTURE(59390-036)

Revised: 2/2020

Document Id: da9272a3-2a0d-4f8b-bb12-f911a9825e5a

Set id: 91426486-d052-4f21-b128-c483bb720f6c

Version: 2

Effective Time: 20200204

Altaire Pharmaceuticals Inc.