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Migraine Relief

ACETAMINOPHEN, ASPIRIN and CAFFEINE · Tablet

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Migraine Relief
Generic name
ACETAMINOPHEN, ASPIRIN and CAFFEINE
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
FSA STORE INC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
13
NDC product codes
7
Packages
8
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the 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 Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
15

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
214039
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 23, 2021
Sponsor
GRANULES
Products on application
1
Submissions recorded
1
Products approved under application 214039.
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
Most recent submissions on application 214039.
Type No. Action Status Date Review
Original application 1 Approved February 23, 2021 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260507 HUMAN OTC DRUG · 20240613

Indications and Usage

openFDA Drug Labeling

USES: Temporarily relieves acute symptoms of migraine headaches such as: •pressure •pulsating •stabbing headache •nausea •sensitivity

USES: Temporarily relieves acute symptoms of migraine headaches such as: •pressure •pulsating •stabbing headache •nausea •sensitivity

Dosage and Administration

openFDA Drug Labeling

Directions ■ 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 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 ■ 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 Labeling

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

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

Active Ingredient

openFDA Drug Labeling

ACTIVE 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.