Leader 12 Hour Sinus Nasal Decongestant

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:09:42

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure

Warnings

Warnings

Directions And Dosage

Directions

adults and children 12 years and over • take 1 tablet every 12 hours • do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

Other Label Information

Other information

• each tablet contains: calcium 45 mg • store at 20-25°C (68-77°F) in a dry place • protect from light • do not use if blister unit is broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

LEADER ™ Maximum Strength | Non-Drowsy 12-Hour Sinus Nasal Decongestant Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg Nasal Decongestant Sinus Pressure + Congestion 10 COATED CAPLETS* *Capsule-shaped Tablets Actual Size COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR active ingredient 100% Money Back Guarantee

Label Images

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Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 120 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over • take 1 tablet every 12 hours • do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 45 mg • store at 20-25°C (68-77°F) in a dry place • protect from light • do not use if blister unit is broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ Maximum Strength | Non-Drowsy 12-Hour Sinus Nasal Decongestant Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg Nasal Decongestant Sinus Pressure + Congestion 10 COATED CAPLETS* *Capsule-shaped Tablets Actual Size COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR active ingredient 100% Money Back Guarantee

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc05452E9C11 Image 1.jpg2025-08-09
otc05452E9C11 Image 2.jpg2025-08-09
otcf020d2ca-7401-4062-9097-17459e554fbc.xml2025-08-09