Nasal Spray

Nasal Spray
SPL v3
SPL
SPL Set ID 5ab118a9-6501-40db-b038-b8234d98ac61
Route
NASAL
Published
Effective Date 2015-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 mg)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Camphor (synthetic) Edetate Disodium Eucalyptol Menthol Cellulose, Microcrystalline Carboxymethylcellulose Polyethylene Glycols Povidone Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-04

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline hydrochloride 0.05%

uses
  • Temporarily relieves nasal congestion due to:
    • Common cold
    • Hay fever
    • Upper respiratory allergies
  • Shrinks swollen nasal membranes so you can breathe more freely
purpose

Nasal Decongestant

warnings

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.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Principal Display

*Compare to the active ingredient in Afrin

Premier Value

Nasal Decongestant

No Drip

​SEVERE CONGESTION

​NASAL SPRAY

Oxymetazoline HCl Nasal Solution

12 HOUR PUMP MIST

Fast, Powerful Congestion Relief

  • Colds 
  • Allergies

Maximum

Strength

plus Menthol

1 FL OZ (30 mL)

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

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

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.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland.
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 Procter & Gamble, distributor of Vicks Sinex.

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.


Structured Label Content

uses (Uses)
  • Temporarily relieves nasal congestion due to:
    • Common cold
    • Hay fever
    • Upper respiratory allergies
  • Shrinks swollen nasal membranes so you can breathe more freely
purpose (Purpose)

Nasal Decongestant

warnings (Warnings)

directions (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.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Principal Display

*Compare to the active ingredient in Afrin

Premier Value

Nasal Decongestant

No Drip

​SEVERE CONGESTION

​NASAL SPRAY

Oxymetazoline HCl Nasal Solution

12 HOUR PUMP MIST

Fast, Powerful Congestion Relief

  • Colds 
  • Allergies

Maximum

Strength

plus Menthol

1 FL OZ (30 mL)

other Information (Other Information)
  • store between 20°-25°C (68°-77°F)
  • retain carton for future reference on full labeling
When Using This Product (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
inactive Ingredients (Inactive Ingredients)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland.
Additional Information Listed On Other Panels (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 Procter & Gamble, distributor of Vicks Sinex.

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.


Advanced Ingredient Data


Raw Label Data

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