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Migraine Relief
ACETAMINOPHEN, ASPIRIN and CAFFEINE · Tablet
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Acetaminophen | 250 mg/1 | 313782 | View |
| Arabica Coffee Bean | 3 [hp_X]/1 | — | — |
| Aspirin | 250 mg/1 | 994535 | View |
| Atropa Belladonna | 6 [hp_X]/1 | 312104 | — |
| Black Cohosh | 6 [hp_X]/1 | — | — |
| Bryonia Alba Root | 6 [hp_X]/1 | — | — |
| Caffeine | 65 mg/1 | 994535 | View |
| Iris Versicolor Root | 6 [hp_X]/1 | — | — |
| Matricaria Chamomilla Whole | 3 [hp_X]/1 | — | — |
| Nitroglycerin | 12 [hp_X]/1 | 237205 | View |
| Passiflora Incarnata Flowering Top | 3 [hp_X]/1 | — | — |
| Sodium Chloride | 6 [hp_X]/1 | 707251 | View |
| Valerian | 3 [hp_X]/1 | — | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Allergens [CS] | CS | 2 members — no class page |
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cell-mediated Immunity [PE] | PE | 2 members — no class page |
| 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 |
| Dietary Proteins [CS] | CS | 1 member — no class page |
| Increased Histamine Release [PE] | PE | 2 members — no class page |
| Methylxanthine [EPC] | EPC | All 30 members |
| Nitrate Vasodilator [EPC] | EPC | All 15 members |
| Nitrates [CS] | CS | All 15 members |
| Non-Standardized Food Allergenic Extract [EPC] | EPC | 1 member — no class page |
| Non-Standardized Plant Allergenic Extract [EPC] | EPC | 1 member — no class page |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
| Plant Proteins [CS] | CS | 1 member — no class page |
| Platelet Aggregation Inhibitor [EPC] | EPC | All 29 members |
| Seed Storage Proteins [CS] | CS | 1 member — no class page |
| Vasodilation [PE] | PE | All 31 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 20260507). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUSES: Temporarily relieves acute symptoms of migraine headaches such as: •pressure •pulsating •stabbing headache •nausea •sensitivity
Purpose
openFDA Drug LabelingUSES: Temporarily relieves acute symptoms of migraine headaches such as: •pressure •pulsating •stabbing headache •nausea •sensitivity
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 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 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 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 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 case of overd …
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: Belladonna 6X, 12X, Bryonia (Alba) 6X, 12X, 18X, Chamomilla 3X, Cimicifuga Racemosa 6X, 12X, 18X, Coffea Cruda 3X, Glonoinum 12X, 18X, Iris Versicolor 6X, 12X, 18X, Natrum Muriaticum 6X, 12X, 18X, Passiflora Incarnata 3X, Valeriana Officinalis 3X
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 57344-205-01 | 57344-205 | AAA PHARMACEUTICAL, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (57344-205-01) / 24 TABLET in 1 BOTTLE, PLASTIC | May 3, 2023 |
| 83324-099-24 | 83324-099 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-099-24) / 24 TABLET in 1 BOTTLE, PLASTIC | May 1, 2024 |
| 53943-305-03 | 53943-305 | DISCOUNT DRUG MART | 1 BOTTLE, PLASTIC in 1 CARTON (53943-305-03) / 100 TABLET in 1 BOTTLE, PLASTIC | January 11, 2024 |
| 81522-205-03 | 81522-205 | FSA STORE INC. | 1 BOTTLE, PLASTIC in 1 CARTON (81522-205-03) / 100 TABLET in 1 BOTTLE, PLASTIC | January 11, 2023 |
| 55319-970-10 | 55319-970 | Family Dollar (FAMILY WELLNESS) | 1 BOTTLE, PLASTIC in 1 BOX (55319-970-10) / 100 TABLET in 1 BOTTLE, PLASTIC | July 1, 2023 |
| 55319-970-24 | 55319-970 | Family Dollar (FAMILY WELLNESS) | 1 BOTTLE, PLASTIC in 1 BOX (55319-970-24) / 24 TABLET in 1 BOTTLE, PLASTIC | July 1, 2023 |
| 72036-305-03 | 72036-305 | HARRIS TEETER | 1 BOTTLE, PLASTIC in 1 CARTON (72036-305-03) / 100 TABLET in 1 BOTTLE, PLASTIC | August 30, 2023 |
| 43689-0017-2 | 43689-0017 | The Magni Company | 1 BOTTLE in 1 CARTON (43689-0017-2) / 90 TABLET in 1 BOTTLE (43689-0017-1) | July 17, 2014 |
| 57344-205 | 57344-205 | AAA PHARMACEUTICAL, INC. | — | May 3, 2023 |
| 83324-099 | 83324-099 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | May 1, 2024 |
| 53943-305 | 53943-305 | DISCOUNT DRUG MART | — | January 11, 2024 |
| 81522-205 | 81522-205 | FSA STORE INC. | — | January 11, 2023 |
| 55319-970 | 55319-970 | Family Dollar (FAMILY WELLNESS) | — | July 1, 2023 |
| 72036-305 | 72036-305 | HARRIS TEETER | — | August 30, 2023 |
| 43689-0017 | 43689-0017 | The Magni Company | — | July 17, 2014 |
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 |
Generated September 25, 2026 · 10 sections on this page.