FDA Label for Nasal Decongestant Extra Moisturizing Premier Value

View Indications, Usage & Precautions

Nasal Decongestant Extra Moisturizing Premier Value Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

* Please review the disclaimer below.