Leader Vapor Ice Cold and Flu

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:25

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each caplet)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant

Uses

Uses

• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

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

• take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other Label Information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

New Formula LEADER ™ Vapor Ice ® Cold & Flu Acetaminophen, 325 mg Dextromethorphan HBr, 10 mg Pain Reliever / Fever Reducer | Cough Suppressant Headache, Fever, Sore Throat Minor Aches & Pains, Cough Non-Drowsy Actual Size COMPARE TO VICKS® DAYQUIL® VAPOCOOL® active ingredients 24 CAPLETS 100% Money Back Guarantee

Label Images

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71P62E9C1-image-2

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Dextromethorphan HBr 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

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

• take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Formula LEADER ™ Vapor Ice ® Cold & Flu Acetaminophen, 325 mg Dextromethorphan HBr, 10 mg Pain Reliever / Fever Reducer | Cough Suppressant Headache, Fever, Sore Throat Minor Aches & Pains, Cough Non-Drowsy Actual Size COMPARE TO VICKS® DAYQUIL® VAPOCOOL® active ingredients 24 CAPLETS 100% Money Back Guarantee

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc7073cce7-5495-4eb7-978f-54e9c7129e10.xml2026-01-16
otc71P62E9C1-image-1.jpg2026-01-16
otc71P62E9C1-image-2.jpg2026-01-16