EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT- phenylephrine hydrochloride spray

Extra Strength Sinus Relief Nasal Decongestant by

Drug Labeling and Warnings

Extra Strength Sinus Relief Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT 
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0132
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0132-1	1 in 1 CARTON	06/06/2017
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/06/2017

Labeler - CARDINAL HEALTH (097537435)