Acetaminophen Extra Strength ACETAMINOPHEN CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain from arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each gelcap) Acetaminophen 500 mg
Inactive Ingredients
Inactive ingredients croscarmellose sodium D&C red #33 FD&C blue #1 FD&C red #40 gelatin hydroxypropyl cellulose hypromellose iron oxide black iron oxide red iron oxide yellow polyethylene glycol povidone pregelatinized starch propylene glycol shellac glaze stearic acid titanium dioxide
Strengths
500 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache The Common Cold Backache Minor Pain From Arthritis Toothache Muscular Aches Premenstrual And Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: blue Imprint: L;5

Identifiers & Packaging

Container Type UNKNOWN
UPC
0096295132335
UNII
362O9ITL9D
Packaging

Principal Display Panel LEADER™ NDC 70000-0312-1 Extra Strength Acetaminophen Gelcaps, 500 mg | Pain Reliever / Fever Reducer Aspirin-Free 50 GELCAPS Actual Size COMPARE TO TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Extra Strength Rapid Release Gels. 50844 REV0525C51915 ©2026 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. Leader 44-519 Leader 44-519

Package Descriptions
  • Principal Display Panel LEADER™ NDC 70000-0312-1 Extra Strength Acetaminophen Gelcaps, 500 mg | Pain Reliever / Fever Reducer Aspirin-Free 50 GELCAPS Actual Size COMPARE TO TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Extra Strength Rapid Release Gels. 50844 REV0525C51915 ©2026 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. Leader 44-519 Leader 44-519

Overview

Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain from arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain from arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Warnings & Precautions
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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number

Questions

Questions or comments? 1-800-426-9391


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