Active Ingredients
Phenylephrine Hydrochloride 1.0 %
Extra Strength Nasal Spray
FDA Label NDC 69842-443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Extra Strength Nasal (NDC 69842-443). 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 ingredients, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Uses
▪ temporarily relieves nasal congestion due to:▪ common cold▪ hay fever▪ upper respiratory allergies (allergic rhinitis)▪ temporarily relieves sinus congestion and pressure▪ shrinks swollen membranes so you can breathe more freely▪ temporarily restores freer breathing through the nose
Do Not Use
If you have ever had an allergic reaction to this product or any of its ingredients
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.▪ temporary discomfort may occur such as burning, stinging, sneezing and increase in nasal discharge▪ 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 for more than 3 days.
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
▪ to spray, squeeze bottle quickly and firmly▪ adults and children 12 years older: 2 or 3 sprays in each nostril not more often than every 4 hours.▪ children under 12 years : ask a doctor
Other Information
▪ store at room temperature
Inactive Ingredients
anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate
Questions
1-866-467-2748
Principal Display
NDC 69842-443-30
Compare to the active ingredient in Extra Strength Neo-Synephrine®*
Extra Strength
Nasal Spray
Phenylephrine hydrochloride 1.0 %
Nasal Decongestant
NON-DROWSY
COLD+ALLERGY
Nasal Congestion RELIEF
You can use every 4 hours
Fast Relief Of:
Sinus Congestion & Pressure
1 FL OZ (30 mL)
*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Extra Strength Neo-Synephrine®.
IMPORTANT: Keep this carton for future reference on full labeling. |
Do not use if printed seal over cap is torn or missing
Distributed by:
* This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine® Extra Strength.
* Please review the disclaimer below.
