EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT- phenylephrine hydrochloride spray 
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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LEADER Extra Strength Sinus Relief Phenylephrine Hydrochloride 1.0% Nasal Decongestant 1 FL OZ

Active ingredients

Phenylephrine Hydrochloride 1.0 %

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

Warnings

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

 
Colds, Allergies

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

www.myleader.com

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.

LEADER  Extra Strength Sinus Relief 1 FL OZ
EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT 
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0132
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0132-11 in 1 CARTON06/06/2017
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/06/2017
Labeler - CARDINAL HEALTH (063997360)

Revised: 10/2023
Document Id: e57de515-a1b5-44cd-9694-b95d6ad91252
Set id: 0d8a009c-30b5-4f12-90bd-f8aa1110243f
Version: 5
Effective Time: 20231004
 
CARDINAL HEALTH