Tension Headache ACETAMINOPHEN CAFFEINE CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses temporarily relieves minor aches and pains due to: headache muscular aches
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg
Inactive Ingredients
Inactive ingredients corn starch crospovidone D&C red #27 aluminum lake FD&C blue #2 aluminum lake FD&C yellow #6 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone sodium starch glycolate stearic acid talc titanium dioxide
Strengths
500 mg 65 mg
Quantities
1979 count
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches
Pill Appearance
Shape: oval Color: red Imprint: 44;428

Identifiers & Packaging

Container Type UNKNOWN
UPC
0096295130287
UNII
362O9ITL9D 3G6A5W338E
Packaging

Principal Display Panel LEADER ™ NDC 70000-0159-1 Tension Headache Acetaminophen, 500 mg Caffeine, 65 mg Pain reliever Pain Reliever Aid Aspirin-Free COMPARE TO EXCEDRIN ® TENSION HEADACHE active ingredients* 100% Money Back Guarantee 24 CAPLETS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark Excedrin® Tension Headache. 50844 REV0824C42808 ©2025 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 100% Money Back Guarantee Return to place of purchase if not satisfied. Leader 44-428 Leader 44-428

Package Descriptions
  • Principal Display Panel LEADER ™ NDC 70000-0159-1 Tension Headache Acetaminophen, 500 mg Caffeine, 65 mg Pain reliever Pain Reliever Aid Aspirin-Free COMPARE TO EXCEDRIN ® TENSION HEADACHE active ingredients* 100% Money Back Guarantee 24 CAPLETS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark Excedrin® Tension Headache. 50844 REV0824C42808 ©2025 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 100% Money Back Guarantee Return to place of purchase if not satisfied. Leader 44-428 Leader 44-428

Overview

Uses temporarily relieves minor aches and pains due to: headache muscular aches

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours. 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: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 heartbeat. 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 any new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days 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 Pain reliever aid

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 any new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Questions

Questions or comments? 1-800-426-9391


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