Leader Dual Action Pain Reliever

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:33

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each caplet)

Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Uses

Uses

• temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis

Warnings

Warnings

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 caplets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Directions And Dosage

Directions

• do not take more than directed Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist Children under 12 years: ask a doctor

Other Label Information

Other information

• read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER TM Dual Action Pain Reliever Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen COMPARE TO ADVIL ® DUAL ACTION active ingredients 36 CAPLETS** **Capsule-Shaped Tablets ACTUAL SIZE 100% Money Back Guarantee

Label Images

dual-action-pain-reliever
dual-action-pain-reliever

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis

Warnings

WARNINGS SECTION

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 caplets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist Children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, 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

LEADER TM Dual Action Pain Reliever Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen COMPARE TO ADVIL ® DUAL ACTION active ingredients 36 CAPLETS** **Capsule-Shaped Tablets ACTUAL SIZE 100% Money Back Guarantee

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/2bb1f616-48af-4fe1-9aa9-32fcb2dba50c/5692f13a-51c6-486c-a57c-b5f99b90aeb9.xml
XML SHA-256
bc7a011f40039acf367d03a5d22d6231fbf9c05e35117a2ef99d18a59ddb9945
XML bytes
36732

Legacy File Index

FolderFileDate
otc5692f13a-51c6-486c-a57c-b5f99b90aeb9.xml2025-10-04
otcdual-action-pain-reliever.jpg2025-10-04