NASAL DECONGESTANT SINUS PREMIER VALUE- oxymetazoline hcl 0.05% spray 
Chain Drug Consortium

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.

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Nasal Spray

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

Benzalkonium Chloride, Edetate Disodium, Polyethylene Glycol, Povidone, Propylene GLycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

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 Sinus.

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 Sinus

Premier Value

Nasal Decongestant

Sinus Nasal Spray

Oxymetazoline HCl 0.05%

Fast Relief Of Stuffy Noses Caused By:

  • Sinusitis
  • Hay Fever

1 FL OZ (30 mL)

image description

NASAL DECONGESTANT SINUS  PREMIER VALUE
oxymetazoline hcl 0.05% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-307
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-307-031 in 1 CARTON11/04/201401/22/2018
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/04/201401/22/2018
Labeler - Chain Drug Consortium (101668460)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(68016-307)

Revised: 1/2018
 
Chain Drug Consortium