Leader Nighttime Cold and Flu

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:54:04

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each 30 mL)

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

Uses

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

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 • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other Label Information

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER ™ Nighttime Cold & Flu Acetaminophen Doxylamine Succinate Dextromethorphan HBr Pain Reliever/Fever Reducer Cough Suppressant Antihistamine Cherry Flavor ALCOHOL 10% COMPARE TO VICKS ® NYQUIL ® COLD & FLU active ingredients 100% Money Back Guarantee 8 FL OZ (237 mL)

Label Images

45934E9F5
45934E9F5

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer Cough suppressant Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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 • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Other information

SPL UNCLASSIFIED SECTION

• each 30 mL contains: sodium 36 mg • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ Nighttime Cold & Flu Acetaminophen Doxylamine Succinate Dextromethorphan HBr Pain Reliever/Fever Reducer Cough Suppressant Antihistamine Cherry Flavor ALCOHOL 10% COMPARE TO VICKS ® NYQUIL ® COLD & FLU active ingredients 100% Money Back Guarantee 8 FL OZ (237 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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otca179ec7e-a683-4741-b016-171bd0f1e5f4.xml2023-07-14
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otc8692da69-54eb-4ab7-907b-f05dfdfcd73b.xml2019-01-04