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FDA Label for Quality Choice

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

Quality Choice Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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



Phenylephrine hydrochloride 1%


Purpose



Nasal decongestant


Uses



for the temporarily relief nasal congestion due to:

  • •common cold
  • •hay fever
  • •upper respiratory allergies

Ask A Doctor Before Use If You Have



  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •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 (1-800-222-1222).


Directions



  • •adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours
  • •children under 12 years of age: ask a doctor

    • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.


Other Information



  • •store at room temperature
  • •container is filled to proper level for best spray action.

Inactive Ingredients



benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate


Questions Or Comments?



1-866-467-2748


Principal Display Panel



NDC# 63868-697-30

*Compare to Active Ingredient in 4-Way® Fast Acting Nasal Spray

Nasal Spray

Nasal Decongestant

PHENYLEPHRINE HCl 1%

For Relief of:

Nasal Congestion

Sinus Congestion

Sinus Pressure

Swollen Nasal Membranes

100% QC SATISFACTION GUARANTEED

1 FL OZ (30 mL)

Distributed by: C.D.M.A. Inc. ©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Novartis Consumer Health, Inc. the owner of the registered trademark 4-Way® Fast Acting Nasal Spray.


* Please review the disclaimer below.