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  5. Label Information: Ultra Fine Mist Sinus Relief

FDA Label for Ultra Fine Mist Sinus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Ultra Fine Mist Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, Inc.. 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 a cold, heavy fever, or other upper respiratory allergies
  • ▪sinus congestion and pressure

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 exceed recommended dosage
  • ▪do not use this product 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 at (1-800-222-1222).


Directions



  • ▪adults & children 6 to under 12 years of age & older (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 2 to under 6 years: ask a doctor
  • ▪children 2 years: do not use

    • To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim.Before using the first time, 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 titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.


Other Information



  • ▪store at room temperature

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# 55910-627-30

Compare to the active ingredient in Vicks® Sinex™ Severe Original*

ULTRA FINE MIST

SINUS RELIEF

Oxymetazoline HCl

Nasal Decongestant

Original

  • •Fast Sinus Congestion & Pressure Relief

    • 12 Hour

    Pump Mist

    1 FL OZ (30 mL)

    IMPORTANT: Keep the carton for future reference on full labeling

    Distributed by:

    *This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks® Sinex™ Severe Original


* Please review the disclaimer below.