Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over: ■ take 2 caplets every 6 hours ■ do not take more than 8 caplets in 24 hours ■ children under 12 years : ask a doctor
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
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ a cold
■ arthritis
■ toothache
■ premenstrual and menstrual cramps
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: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 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 ■ take more or for a longer time than directed ■ 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
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.
■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ you have liver disease
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ you have asthma
■ you are taking a diuretic
■ taking a prescription drug for diabetes, gout, or arthritis
■ taking any other drug or are under a doctor’s care for any serious condition
■ an allergic reaction occurs. Seek medical help right away.
■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ have bloody or black stools ■ vomit blood
■ have stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ painful area is red or swollen
■ any new symptoms appear.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not use more than directed
■ drink a full glass of water with each dose
■
adults and children 12 years and over:
■ take 2 caplets every 6 hours
■ do not take more than 8 caplets in 24 hours
■
children under 12 years: ask a doctor
■ Store in a dry place at 15°-30°C (59°-86°F)
■ use by expiration date on package
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
1-800-231-4670
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
†This product is not manufactured or distributed by Haleon, owner of the registered trademark Excedrin® Extra Strength.
©2026 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
CIN 6159925 REV. 08/26
Leader
NDC 70000-0777-1
Extra Strength
Headache Relief
Acetaminophen
Aspirin (NSAID)*/Caffeine
Pain Reliever/Pain Reliever Aid
COMPARE TO EXCEDRIN® EXTRA STRENGTH active ingredients†
100 CAPLETS
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0066-1 | EA - Each | 70000-0066 | 3638dec4-066d-4174-ae2b-76b323e007ab | 1 | 2021-08-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0777 | 70000-0777-1 |
| 70000-0066 | 70000-0066-1 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-02-11 | full-release | 2026-06-01 00:54:58 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | LEADER/ Cardinal Health 110, Inc. | b3773f02-02a9-33c8-e053-2995a90a2235 | 2025-02-11 | Warnings | 70000-0066-1 70000-0066 70000006601 b3773f02-02a9-33c8-e053-2995a90a2235 |
Adverse event summaries are temporarily unavailable. Other product information remains available.