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Acetaminophen, Aspirin and Caffeine
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Central Nervous System Stimulant [EPC] | EPC | All 93 members |
| Central Nervous System Stimulation [PE] | PE | All 95 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Decreased Platelet Aggregation [PE] | PE | All 39 members |
| Decreased Prostaglandin Production [PE] | PE | All 54 members |
| Methylxanthine [EPC] | EPC | All 30 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
| Platelet Aggregation Inhibitor [EPC] | EPC | All 29 members |
| Xanthines [CS] | CS | All 30 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 214039-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | TABLET | ACETAMINOPHEN; ASPIRIN; CAFFEINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | February 23, 2021 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251219). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
Purpose
openFDA Drug LabelingPURPOSE Pain reliever Pain reliever Pain reliever aid
Dosage and Administration
openFDA Drug LabelingDirections do not take 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 Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) close cap tightly after use read all product information before using.
Warnings
openFDA Drug LabelingReye’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 severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: 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 2 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
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month
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.
Do Not Use
openFDA Drug LabelingDo 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
openFDA Drug LabelingAsk a doctor before use if • you have never had migraines diagnosed by a health professional • you have a headache that is different from your usual migraines • you have the worst headache of your life • you have fever and stiff neck • you have headaches beginning after or caused by head injury, exertion, coughing or bending • you experienced your first headache after the age of 50 • you have daily headaches • you have a migraine so severe as to require bed rest • 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 • you have problems or serious side effects from taking pain relievers or fever reducers • you have vomiting with your migraine headache
Stop Use
openFDA Drug LabelingStop 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present any new symptoms occur. These could be signs of a serious condition
Active Ingredient
openFDA Drug LabelingDO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED Drug Facts Active ingredients (in each caplet) Purposes Acetaminophen USP, 250 mg...............................................................Pain reliever Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever Caffeine USP, 65 mg........................................................................Pain reliever aid *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 55319-680-10 | 55319-680 | FAMILY DOLLAR | 100 TABLET in 1 BOTTLE (55319-680-10) | September 1, 2023 |
| 62207-680-47 | 62207-680 | Granules India Ltd | 500 TABLET in 1 BOTTLE (62207-680-47) | April 15, 2021 |
| 62207-680-51 | 62207-680 | Granules India Ltd | 1 BOTTLE in 1 CARTON (62207-680-51) / 10 TABLET in 1 BOTTLE | April 15, 2021 |
| 62207-680-98 | 62207-680 | Granules India Ltd | 22500 TABLET in 1 BOX (62207-680-98) | April 15, 2021 |
| 62207-680-99 | 62207-680 | Granules India Ltd | 4500 TABLET in 1 POUCH (62207-680-99) | April 15, 2021 |
| 57237-348-01 | 57237-348 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (57237-348-01) | July 9, 2025 |
| 21130-681-05 | 21130-681 | Safeway, Inc | 50 TABLET in 1 BOTTLE (21130-681-05) | August 4, 2023 |
| 21130-681-10 | 21130-681 | Safeway, Inc | 100 TABLET in 1 BOTTLE (21130-681-10) | August 4, 2023 |
| 21130-681-24 | 21130-681 | Safeway, Inc | 24 TABLET in 1 BOTTLE (21130-681-24) | August 4, 2023 |
| 71309-079-03 | 71309-079 | Safrel Pharmaceuticals, LLC. | 300 TABLET in 1 BOTTLE (71309-079-03) | April 15, 2021 |
| 55319-680 | 55319-680 | FAMILY DOLLAR | — | September 1, 2023 |
| 62207-680 | 62207-680 | Granules India Ltd | — | April 15, 2021 |
| 57237-348 | 57237-348 | Rising Pharma Holdings, Inc. | — | July 9, 2025 |
| 21130-681 | 21130-681 | Safeway, Inc | — | August 4, 2023 |
| 71309-079 | 71309-079 | Safrel Pharmaceuticals, LLC. | — | April 15, 2021 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.