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migraine relief
acetaminophen, aspirin, caffeine · Tablet, Film Coated
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 |
|---|---|---|---|---|---|---|---|
| 075794-001 | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | TABLET | ACETAMINOPHEN; ASPIRIN; CAFFEINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 45 | Manufacturing (CMC) | Approved | February 26, 2016 | — |
| Supplement | 40 | Labeling | Approved | December 12, 2014 | Standard |
| Supplement | 30 | Labeling | Approved | November 22, 2010 | — |
| Supplement | 26 | Labeling | Approved | March 5, 2008 | — |
| Supplement | 22 | Labeling | Approved | November 21, 2006 | — |
| Supplement | 12 | Labeling | Approved | December 17, 2003 | — |
| Supplement | 8 | Labeling | Approved | October 8, 2003 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | August 16, 2002 | — |
| Supplement | 3 | Labeling | Approved | August 16, 2002 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | August 16, 2002 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | August 16, 2002 | — |
| Original application | 1 | Approved | November 26, 2001 | — |
Review documents
- 0 · Original application · April 15, 2003
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260824). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse • treats migraine
Purpose
openFDA Drug LabelingPurposes Pain reliever Pain reliever aid
Dosage and Administration
openFDA Drug LabelingDirections • do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 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: 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 geltabs 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 severe nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. 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 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 migraine headache Ask a doctor or pharmacist before use if you are • taking a prescription drug for: • diabetes • gout • arthritis • under a doctor’s care for any serious condition • taking any other drug • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs 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 cas …
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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs
Active Ingredient
openFDA Drug LabelingActive ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *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 |
|---|---|---|---|---|
| 72288-286-27 | 72288-286 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-286-27) / 80 TABLET, FILM COATED in 1 BOTTLE (72288-286-00) | September 11, 2026 |
| 59779-374-62 | 59779-374 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-374-62) / 24 TABLET, FILM COATED in 1 BOTTLE | August 27, 2002 |
| 59779-374-82 | 59779-374 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-374-82) / 200 TABLET, FILM COATED in 1 BOTTLE | May 21, 2013 |
| 59779-374-87 | 59779-374 | CVS Pharmacy | 300 TABLET, FILM COATED in 1 BOTTLE (59779-374-87) | September 21, 2018 |
| 30142-896-62 | 30142-896 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-896-62) / 24 TABLET, FILM COATED in 1 BOTTLE | October 25, 2022 |
| 30142-896-78 | 30142-896 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-896-78) / 100 TABLET, FILM COATED in 1 BOTTLE | October 9, 2019 |
| 11822-0374-1 | 11822-0374 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-0374-1) / 100 TABLET, FILM COATED in 1 BOTTLE | May 14, 2002 |
| 11822-0374-2 | 11822-0374 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-0374-2) / 24 TABLET, FILM COATED in 1 BOTTLE | May 14, 2002 |
| 11822-0374-5 | 11822-0374 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-0374-5) / 50 TABLET, FILM COATED in 1 BOTTLE | May 14, 2002 |
| 11822-0374-7 | 11822-0374 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-0374-7) / 200 TABLET, FILM COATED in 1 BOTTLE | April 22, 2020 |
| 0363-0374-78 | 0363-0374 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0374-78) / 100 TABLET, FILM COATED in 1 BOTTLE | May 2, 2002 |
| 0363-0374-82 | 0363-0374 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0374-82) / 200 TABLET, FILM COATED in 1 BOTTLE | May 2, 2002 |
| 0363-1235-27 | 0363-1235 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-1235-27) / 80 TABLET, FILM COATED in 1 BOTTLE | January 9, 2025 |
| 0363-1235-60 | 0363-1235 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-1235-60) / 20 TABLET, FILM COATED in 1 BOTTLE | June 16, 2022 |
| 72288-286 | 72288-286 | Amazon.com Services LLC | — | September 11, 2026 |
| 59779-374 | 59779-374 | CVS Pharmacy | — | August 27, 2002 |
| 30142-896 | 30142-896 | Kroger Company | — | October 9, 2019 |
| 11822-0374 | 11822-0374 | Rite Aid Corporation | — | May 14, 2002 |
| 0363-0374 | 0363-0374 | Walgreen Company | — | May 2, 2002 |
| 0363-1235 | 0363-1235 | Walgreen Company | — | June 16, 2022 |
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 · 11 sections on this page.