Leader Extra Strength Sinus Relief Phenylephrine Hydrochloride 1.0% Nasal Decongestant 1 Fl Oz

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (1 g)

Inactive Ingredients

Anhydrous Citric Acid Benzalkonium Chloride Benzyl Alcohol Water Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-06-06

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine Hydrochloride 1.0 %

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

Questions

1-866-467-2748

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

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients

Other Information

store at room temperature
Protect from light.

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

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.

Active Ingredients

Phenylephrine Hydrochloride 1.0 %

Inactive Ingredients

anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate

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

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

Structured Label Content

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

Purpose

Nasal decongestant

Questions

1-866-467-2748

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

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)

store at room temperature
Protect from light.

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

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.

Active Ingredients (Active ingredients)

Phenylephrine Hydrochloride 1.0 %

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist for more than 3 days.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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 1-800-222-1222

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Nasal decongestant", "Questions": "1-866-467-2748", "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", "Do Not Use": "If you have ever had an allergic reaction to this product or any of its ingredients", "Other information": "store at room temperature Protect from light.", "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.", "Active ingredients": "Phenylephrine Hydrochloride 1.0 %", "Inactive ingredients": "anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate", "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", "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"}

Leader Extra Strength Sinus Relief Phenylephrine Hydrochloride 1.0% Nasal Decongestant 1 Fl Oz

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information