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FDA Label for Publix

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

Publix Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets, 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



Phenylephrine hydrochloride 1%


Purpose



Nasal decongestant


Uses



for the temporary relief of 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 exceed recommended dosage
  • ▪do not use for more than 3 days. Use only as directed.
  • ▪temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • ▪the use of this container by more than one person may spread infection
  • ▪frequent or prolonged use may cause nasal congestion to recur or worsen

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 and children 12 years of age & older: 2 or 3 sprays 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?



1-888-267-3037


Principal Display Panel



COMPARE TO the active ingredient 4-Way® Fast Acting Nasal Spray

NDC 41415-728-30

Publix®

Nasal Spray

NASAL DECONGESTANT

PHENYLEPHRINE HYDROCHLORIDE 1 %

Fast acting relief of:

  • •Nasal congestion
  • •Sinus congestion
  • •Sinus pressure
  • •Swollen nasal membranes

    • 1 FL OZ (30mL)

    DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

    DISTRIBUTED BY

    PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY,

    LAKELAND, FL 33811

    publix.com, 1-888-267-3037

    PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK.

    IMPORTANT: Keep this carton for future reference on full labeling.

    *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.