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Walgreens 12-Hour Sinus Relief

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05mL in 100mL
Labeler: Walgreen Company
NDC Code: 0363-0314

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.

Walgreens 12 Hour Sinus Relief Mist

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Usestemporarily relieves sinus/nasal congestion due to:
• colds
• hay fever
• upper respiratory allergies

Warnings Do not use

this container by more than one person; it may spread infection.
for more than 3 days.

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

do not exceed recommended dosage
temporary burning, stinging, sneezing or an increase in nasal discharge may occur
frequent or prolonged use of this product may cause nasal congestion to recur or worsen.

Stop use and ask a doctor if

symptoms persist for more than 3 days.

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DirectionsShake well before use. Before using the first time, remove the protective cap from the tip and prime pump by depressing its rim several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after each use.

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 in any 24-hour period.
children under 6 years of age: consult a doctor

Other Information

store at room temperature

Inactive Ingredients

benzalkonium chloride, camphor, chlorhexidine gluconate, edetate disodium, eucalyptol, menthol, potassium phosphate
monobasic, purified water, sodium chloride, sodium phosphate dibasic, tyloxapol

Distributed by: Walgreen Co
200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back. www.walgreens.com

Compare to Vicks Sinex active ingredient

Walgreens

12 Hour Sinus Relief Mist

Oxymetazoline HCL - 0.05% Nasal Decongestant

12HOUR sinus relief

This product is not manufactured or distributed by Procter and Gamble., the distributor of Vicks(R) Sinex(R)

IMPORTANT:
Keep this carton for future reference on full labeling.

Carton Packaging

Container Label

WALGREENS 12-HOUR SINUS RELIEF
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0314
Route of Administration	NASAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE)	OXYMETAZOLINE HYDROCHLORIDE	0.05 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE
CAMPHOR (SYNTHETIC)
CHLORHEXIDINE GLUCONATE
EDETATE DISODIUM
EUCALYPTOL
MENTHOL
POTASSIUM PHOSPHATE, MONOBASIC
WATER
SODIUM CHLORIDE
SORBITOL
TYLOXAPOL

Packaging
#	Item Code	Package Description
1	NDC:0363-0314-21	1 BOTTLE, SPRAY (BOTTLE) in 1 BOX
1		15 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2011

Labeler - Walgreen Company (008965063)

Revised: 08/2011

Document Id: 3685df19-0029-4e60-95d2-4ddb1e055fe2

Set id: a5946414-f944-4a85-a43e-cde602ec2051

Version: 1

Effective Time: 20110801

Walgreen Company

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Walgreens 12-Hour Sinus Relief

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