Leader Migraine Relief

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-01-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:34:02

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each caplet)

Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever Pain reliever aid

Uses

Use

• treats migraine

Warnings

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 2 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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 Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Directions And Dosage

Directions

• do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: ask a doctor

Other Label Information

Other information

• store at 20 ° -25 ° C (68 ° -77 ° F) • close cap tightly after use • read all product information before using. Keep this box for important information.

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

LEADER ™ Migraine Relief Acetaminophen | Aspirin (NSAID) | Caffeine Tablets Pain Reliever / Pain Reliever Aid COMPARE TO EXCEDRIN ® MIGRAINE RELIEF active ingredients 100 COATED CAPLETS** **Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee

Label Images

374-e9-migraine-relief
374-e9-migraine-relief

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever Pain reliever aid

Use

INDICATIONS & USAGE SECTION

• treats migraine

Warnings

WARNINGS SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 2 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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 Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at 20 ° -25 ° C (68 ° -77 ° F) • close cap tightly after use • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER ™ Migraine Relief Acetaminophen | Aspirin (NSAID) | Caffeine Tablets Pain Reliever / Pain Reliever Aid COMPARE TO EXCEDRIN ® MIGRAINE RELIEF active ingredients 100 COATED CAPLETS** **Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
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otc69f4c63a-5e24-40ca-be58-2232c6b51abd.xml2026-01-21
otcdb3fd8b0-2223-4bb1-89e7-62391d9b341a.xml2023-03-31
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otc80a74487-2d04-45a0-9dd0-0941a8a47a53.xml2021-06-20
otc8dff64e7-ede6-4e82-9dfe-dafc3b2fda90.xml2019-12-11
otc374 E9 migraine-relief-image.jpg2018-07-25
otcd088038c-a035-4f25-a25a-e731358a5c58.xml2018-07-25