QUALITY CHOICE- oxymetazoline hydrochloride spray

Quality Choice by

Drug Labeling and Warnings

Quality Choice by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

temporarily relieves nasal congestion due to:

• a cold
• hay fever
• upper respiratory allergies
• promotes nasal and sinus drainage
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages; shrinks swollen nasal membranes

Warnings

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 (1-800-222-1222).

Directions

• 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: ask a doctor

Shake well before use: Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap.

Rotate the lock tab to align arrow marks to unlock the pump. Prime the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times.

To spray, hold bottle with thump 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Other information

• store at room temperature
• retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC# 63868-699-22

QUALITY CHOICE®

*Compare to Active Ingredient in Mucinex® Full Force Nasal Spray

12 Hour Relief

Nasal Spray

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast Relief of Sinus Pressure & Nasal Congestion

3/4 FL OZ (22 mL)

100% QC SATISFACTION GUARANTEED

Distributed by C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Full Force™ Nasal Spray.

INGREDIENTS AND APPEARANCE

QUALITY CHOICE 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-699
Route of Administration	NASAL

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 (NATURAL) (UNII: N20HL7Q941)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-699-22	1 in 1 CARTON	12/17/2018
1		22 mL in 1 BOTTLE, PUMP; 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	12/17/2018

Labeler - CHAIN DRUG MARKETING ASSOCIATION (011920774)