MAXIMUM STRENGTH NASAL DECONGESTANT- oxymetazoline spray liquid

Maximum Strength Nasal Decongestant by

Drug Labeling and Warnings

Maximum Strength Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by CVS Health, Sheffield Pharmaceuticals LLC, Sheffield Pharmaceutical LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiroty allergies
• temporaily relieves sinus congestion and pressure
• Shrinks swollen membranes so you can breathe more freely

Warnings

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyiod diease
• trouble urinating due to enlarged rostate gland.

When using this product

• Do not use more than directed
• do not use for more than three 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 the reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Before using for the first time, remove the protective cap form the tip and prime the 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 nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
• Wipe nozzle clean after use.
• Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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 between 20° and 25°C (68° to 77°F)
• retain carton for future reference on full labeling

Inactive Ingredients

Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Panel 0.5 FLOZ Bottle

CVS Health    Severe Congestion

Maxium Strength

Nasal Spray 

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal display panel- Bottle back label

Principal display panel -Carton

CVS Health Severe Congestion

Maxium Strength

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH NASAL DECONGESTANT 
oxymetazoline spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-316
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	50 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EUCALYPTOL (UNII: RV6J6604TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-316-51	1 in 1 CARTON	08/30/2018
1		15 mL in 1 BOTTLE, SPRAY; 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	08/30/2018

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceutical LLC		151177797	manufacture(69842-316)