leader tussin cf

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:47:26

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each 20 mL)

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Purposes

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Uses

• temporarily relieves these symptoms occurring with a cold or flu: • cough due to minor throat and bronchial irritation • nasal congestion • sinus congestion and pressure • 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

Other information

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

Inactive ingredients

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, 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 ™ Adult | Maximum Strength Tussin CF Severe Multi-Symptom Cough Cold + Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant Raspberry Flavor Ages 12 Years and Over Relieves: Cough, Sore Throat, Body Aches, Fever, Nasal Congestion, Chest Congestion Non-Drowsy COMPARE TO ROBITUSSIN ® SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients 100% Money Back Guarantee 4 FL OZ (118 mL)

Label Images

image-01
image-01

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms occurring with a cold or flu: • cough due to minor throat and bronchial irritation • nasal congestion • sinus congestion and pressure • 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

STORAGE AND HANDLING SECTION

• 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, polyethylene glycol, 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 ™ Adult | Maximum Strength Tussin CF Severe Multi-Symptom Cough Cold + Flu Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCl Pain Reliever/Fever Reducer Cough Suppressant Expectorant Nasal Decongestant Raspberry Flavor Ages 12 Years and Over Relieves: Cough, Sore Throat, Body Aches, Fever, Nasal Congestion, Chest Congestion Non-Drowsy 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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Legacy File Index

FolderFileDate
otcb82ad95f-84c2-401a-8eab-91cc1dc22a70.xml2026-02-27
otccff256ec-17dd-4c0d-aac2-150ad2f62ab4.xml2024-11-06
otcb3e3699b-b36c-453c-8f3b-0001388c8e82.xml2023-02-02
otcimage-01.jpg2023-02-02