FDA Label for Publix
View Indications, Usage & Precautions
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
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.