Otc - Active Ingredient
Phenylephrine hydrochloride 1.0%
Neo-synephrine Maximum Spray
FDA Label NDC 0225-0810
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bf Ascher And Co Inc for the product Neo-synephrine Maximum (NDC 0225-0810). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Nasal decongestant
Indications & Usage
Temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
Temporarily relieves sinus congestion and pressure
Shrinks swollen membranes so you can breathe more freely
Temporarily restores freer breathing through the nose.
Warnings
When using this product:
- 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.
- use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Do not use more than directed.
Do not use for more than 3 days.
Otc - Ask Doctor
Ask a doctor before use if you have:
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Stop use and as a doctor if symptoms persist.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- to spray, squeeze bottle quickly and firmly
- adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours
- Children under 12 years of age: ask a doctor
Storage And Handling
- Store at room temperature, 59° - 86° F (15° -30° C)
- Retain carton for future reference on full labeling
Inactive Ingredient
anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate
Otc - Questions
Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com
Package Label.Principal Display Panel
Neo-synephrine Extra Strength (Neoextra)
* Please review the disclaimer below.
