Active Ingredients
Phenylephrine Hydrochloride 1.0 %
Extra Strength Sinus Relief Nasal Decongestant Spray
FDA Label NDC 70000-0132
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Extra Strength Sinus Relief Nasal Decongestant (NDC 70000-0132). 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
- due to hay fever or other upper respiratory allergies (allergic rhinitis)
- temporarily relieves stuffy nose.
- helps clear nasal passages; shrinks swollen membranes
- temporarily restores freer breathing through the nose
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
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
- difficulty in urination due to enlargement of the prostate gland
When Using This Product
• do not exceed recommended dosage
• 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 may occur such as burning, stinging, sneezing and increase in nasal discharge
• use of this container by more than one person may spread infection
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
- Use only as directed
- 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
- Protect from light.
Inactive Ingredients
anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate
Questions
1-866-467-2748
Principal Display
LEADER
NDC 70000-0132-1
COMPARE TO NEO-SYNEPHRINE® EXTRA STRENGTH active ingredient
Extra Strength
Sinus Relief
Phenylephrine hydrochloride 1.0 %
Nasal Decongestant
Fast Relief Of:
Sinus Congestion & Pressure
1 FL OZ (30 mL)
* This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine®Extra Strength.
IMPORTANT: Keep this carton for future reference on full labeling. |
Do not use if printed seal over cap is torn or missing
©2017 Cardinal Health, All Rights Reserved , CARDINAL HEALTH ,the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.
Cardinal Health™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to care™ since 1979
* 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.
