LEADER TUSSIN CF

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:31

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each 20 mL)

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purposes

Pain reliever/fever reducer Cough suppressant Expectorant

Uses

Uses

• temporarily relieves these symptoms occurring with a cold or flu: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions And Dosage

Directions

• do not take more than 5 doses in any 24-hour period • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use

Other Label Information

Inactive ingredients

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label principal display panel

LEADER ™ New Formula Adult | Maximum Strength Tussin CF Severe Multi-Symptom Cough Cold + Flu Acetaminophen Dextromethorphan HBr Guaifenesin Pain Reliever / Fever Reducer Cough Suppressant Expectorant Raspberry Flavor Ages 12 Years and Over Relieves: Cough, Sore Throat, Head & Body Aches, Fever, Chest Congestion Thins & Loosens Mucus COMPARE TO ROBITUSSIN ® SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients 100% Money Back Guarantee 4 FL OZ (118 mL)

Label Images

leader-tussin-cf-raspberry-carton-image
leader-tussin-cf-raspberry-carton-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Expectorant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms occurring with a cold or flu: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than 5 doses in any 24-hour period • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use

Other information

OTHER SAFETY INFORMATION

• each 20 mL contains: sodium 14 mg • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ New Formula Adult | Maximum Strength Tussin CF Severe Multi-Symptom Cough Cold + Flu Acetaminophen Dextromethorphan HBr Guaifenesin Pain Reliever / Fever Reducer Cough Suppressant Expectorant Raspberry Flavor Ages 12 Years and Over Relieves: Cough, Sore Throat, Head & Body Aches, Fever, Chest Congestion Thins & Loosens Mucus COMPARE TO ROBITUSSIN ® SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients 100% Money Back Guarantee 4 FL OZ (118 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
30740

Legacy File Index

FolderFileDate
otcb8bbcafc-ef05-4fe1-b3bd-91f3d84f67aa.xml2025-10-03
otcleader-tussin-cf-raspberry-carton-image.jpg2025-10-03