Indications and uses
Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & 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; not more than 8 caplets in 24 hours • children under 12 years: ask a doctor
store at 20°-25°C(68°-77°F) close cap tightly after use DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)**
Caffeine 65 mg
**nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliever aid
Temporarily relieves minor aches and pains due to:
• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual & 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:Acetaminophen may cause 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 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 • 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
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 occasional rapid heartbeat.
Do not use• 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.
Ask a doctor before use if • 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 are taking a diuretic • you have asthma
Ask a doctor or pharmacist before use if you are
• taking aa prescription drug for diabetes, gout, or arthritis
• taking any other drug, or are under a doctor's care for any serious condition
Stop use and ask a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
• feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms occur
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 at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222)right away. Quick medical attention is critical for adults as well as 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; not more than 8 caplets in 24 hours
•
children under 12 years:ask a doctor
colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVPK-30, sodium starch glycolate, stearic acid, talc, titanium dioxide.
call toll-free 1-844-912-4012
NDC 37835-531-01
Compare to the active ingredients in Excedrin® Extra Strength*
Extra Strength
Acetaminophen, Aspirin (NSAID)**, and Caffeine
Pain Reliever/ Pain Reliever Aid
100 Caplets
*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.
Distributed by:
BI-MART
Eugene, OR 97402
NDC 37835-531-25
Compare to the active ingredients in Excedrin® Extra Strength*
Extra Strength
Acetaminophen, Aspirin (NSAID)**, and Caffeine
Pain Reliever/ Pain Reliever Aid
250 Caplets
*This product is not manufactured or distributed by the owner of the registered trademark Excedrin ®Extra Strength.
Distributed by:
BI-MART
Eugene, OR 97402
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37835-531-01 | Acetaminophen, Aspirin, and Caffeine | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 37835-531-25 | Acetaminophen, Aspirin, and Caffeine | 250 in 1 BOTTLE | TABLET | 250 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37835-531 | 37835-531-01, 37835-531-25 |
Every source-derived ingredient row is available through these pages.
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, and Caffeine | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Bi-Mart | 40cd1a7a-e941-4503-8fe4-e939bd0d9d72 | 2025-07-02 | Warnings | 37835-531-01 37835-531-25 37835-531 37835053101 37835053125 38f72774-7c51-b84f-e063-6394a90a8e64 40cd1a7a-e941-4503-8fe4-e939bd0d9d72 |
Adverse event summaries are temporarily unavailable. Other product information remains available.