NASAL DECONGESTANT EXTRA MOISTURIZING PREMIER VALUE- 0.05% oxymetazoline hcl spray

Nasal Decongestant Extra Moisturizing by

Drug Labeling and Warnings

Nasal Decongestant Extra Moisturizing by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, Product Quest Mfg. 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:
  • Common cold
  • Hay fever
  • Upper respiratory allergies
• Shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• 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 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 within any 24-hour period.
• Children under 6 years of age: Ask a doctor.

Shake well before use. Before using for the first time remove the protective cap from the tip and prime metered 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 each use.

Other Information

• store between 20°-25°C (68°-77°F)
• retain carton for future reference on full labeling

Inactive Ingredients

Benzalkonlum Chloride, Benzyl Alcohol, Edetate Disodium, Flavor, Glycerin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Carboxymethyl Cellulose, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water.

Additional information listed on other panels

SAFETY SEALED: DO NOT USE IF IMPRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.

*This product is not manufactured or distributed by MSD Consumer Care, INC., distributor of Afrin Extra Moisturizing.

Distributed By:

Chain Drug Consortium

3301 NW Boca Raton Blvd, Suite 101

Boca Raton, FL 33431

Made in USA

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Principal Display

*Compare to the active ingredient in Afrin Extra Moisturizing

Premier Value

Nasal Decongestant

Extra Moisturizing Nasal Spray

Oxymetazoline HCl 0.05%

Fast, Powerful Congestion Relief

• Colds

• Allergies

Helps Rehydrate

Dry Nasal Passages

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT EXTRA MOISTURIZING  PREMIER VALUE
0.05% oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-304
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-304-03	1 in 1 CARTON
1		30 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	11/04/2014

Labeler - Chain Drug Consortium (101668460)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(68016-304)