Publix Spray
FDA Label NDC 41415-716

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix (NDC 41415-716). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

  • ▪for the temporarily relief of nasal congestion due to:
    • ▪common cold
    • ▪hay fever
    • ▪upper respiratory allergies
    • ▪temporarily relieves sinus congestion and pressure
    • ▪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 at (1-800-222-1222).

Directions

  • adults and children 6 to under 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 in any 24-hour period.
  • children under 6 years of age: ask a doctor

    • Sake well before use: Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. 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 use. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip

Other Information

  • store at room temperature

    • How to use:

    Push down cap while turning counterclockwise and remove cap. Remove clip under rim. Secure cap after use.

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Questions Or Comments?

1-888-267-3037

Principal Display Panel

Publix®

NDC# 41415-716-30

Compare to the active ingredient in Afrin® No Drip Original Pump Mist

ORIGINAL

nasal mist

NASAL DECONGESTANT

OXYMETAZOLINE HCL 0.05%

12 HOUR PUMP MIST WON’T DRIP FROM NOSE OR DOWN THROAT

  • Fast & effective congestion relief
  • For colds & allergies

    • 1 FL OZ (30 mL)

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

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY,

    LAKELAND, FL 33811

    1-888-267-3037 publix.com

    PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

    *This product is not manufactured or distributed by Bayer Healthcare LLC, distributer of Afrin® Original.

* Please review the disclaimer below.