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12 Hour Nasal by Altaire Pharmaceuticals Inc.

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: Altaire Pharmaceuticals Inc.
NDC Code: 59390-036

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.

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)

12 HOUR NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-036
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SODIUM PHOSPHATE, MONOBASIC 
WATER 
SODIUM CHLORIDE 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:59390-036-131 BOTTLE, SPRAY in 1 CARTON
115 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2001
Labeler - Altaire Pharmaceuticals Inc. (786790378)
Establishment
NameAddressID/FEIOperations
Altaire Pharmaceuticals Inc.786790378MANUFACTURE(59390-036)

Revised: 06/2014
 
Altaire Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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