SEVERE CONGESTION NASAL NO DRIP WALGREENS- oxymetazoline hydrochloride 0.05% liquid

Severe Congestion Nasal no drip by

Drug Labeling and Warnings

Severe Congestion Nasal no drip by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                       Purpose

Oxymetazoline Hydrochloride 0.05%        Nasal decongestant

PURPOSE

INDICATIONS & USAGE

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

do not exceed recommended dosage do not use for more than 3 days. Use only as directed. may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge the use of this container by more than one person may spread infection frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor if symptoms persist

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Before using the first time, remove the protective cap from the tip and prime pump by depressing pump firmly 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 use. adults and children 6 to under1 2 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 1 0 to 1 2 hours. Do not exceed 2 doses within any 24-hour period children under 6 years of age: consult a doctor

Inactive ingredients

Benzalkonium Chloride, Benzyl Alcohol, Camphor, Edetate Disodium, Eucalyptol, Menthol, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION NASAL NO DRIP  WALGREENS
oxymetazoline hydrochloride 0.05% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Benzyl Alcohol (UNII: LKG8494WBH)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
Edetate Disodium (UNII: 7FLD91C86K)
Eucalyptol (UNII: RV6J6604TK)
Menthol (UNII: L7T10EIP3A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
Povidone (UNII: FZ989GH94E)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7001-01	1 in 1 CARTON	07/01/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2016

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(0363-7001) , label(0363-7001)