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: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 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 have asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ taking a 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
■ 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
■ an allergic reaction occurs. Seek medical help right away.
■ 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
(800) 231-4670
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
DISTRIBUTED BY: RUGBY® LABORATORIES
INDIANAPOLIS, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com
†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0368071391411 | GTIN-13: 0368071391411 EAN-13: 0368071391411 GTIN-12: 368071391411 UPC-A: 368071391411 GTIN storage (14 digits): 00368071391411 | 68071-3914-1.jpg |
| Data code | Data Matrix | 0100368071391411210000000002<GS>170000010000000<GS> | 68071-3914-1.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3914-1 | Acetaminophen, Aspirin, Caffeine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 68071-3914-1 | Acetaminophen, Aspirin, Caffeine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1326-01 | EA - Each | 0536-1326 | 0d809eff-8115-4130-a21f-1cebfd60ea38 | 1 | 2021-07-15 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-3914 | 68071-3914-1 |
| 0536-1326 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYDEXTROSE | VH2XOU12IE | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Pain Reliever Plus | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Rugby Laboratories | c3df1652-96a8-6043-e053-2995a90a2d26 | 2026-07-07 | Warnings | 0536-1326 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | 68071-3914-1 68071-3914 68071391401 437e4fe5-baed-1534-e063-6394a90a22d4 437e4fd9-c7d9-77d6-e063-6294a90a22b7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.