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Migraine Relief
acetaminophen, aspirin and caffeine · Migraine Relief is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin and caffeine, made by 5 manufacturers.
- Type
- Over the counter
- Drug class
- Central Nervous System Stimulant
- Route
- Oral
- Manufacturers
- 5
■ treats migraine
Drug facts
- Generic name
- acetaminophen, aspirin and caffeine
- Active ingredients
- Acetaminophen, Aspirin, Caffeine
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- How it works
- Cyclooxygenase Inhibitors
- Dosage forms
- Tablet
- Label holder
- HARRIS TEETER
- FDA application
- ANDA214039
- Label updated
- 08/05/2026
Active ingredients
(s) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug Purpose Pain reliever Pain reliever Pain reliver aid
Purpose
Pain reliever Pain reliever Pain reliver aid
Uses
- Treats migraine
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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
- 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
- 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
Pregnancy or breastfeeding
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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information
- Store at controlled room temperature 20º to 25ºC (68º to 77ºF)
- Close cap tightly after use
- Read all product information before using.
- Keep this box for important information
Inactive ingredients
Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide
Questions?
1-844-705-4384
Forms and strengths
From the FDA NDC Directory · 5 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 250 mg / 250 mg / 65 mg | oral | 5 |
Manufacturers and labels
5 FDA labels
- HARRIS TEETERShown hereANDA214039 · Label 08/05/2026 · NDC 72036-305Full label
- AAA PHARMACEUTICAL, INC.ANDA214039 · Label 05/03/2023 · NDC 57344-205Full label
- CHAIN DRUG MARKETING ASSOCIATION, INC.ANDA214039 · Label 06/13/2024 · NDC 83324-099Full label
- DISCOUNT DRUG MARTANDA214039 · Label 06/13/2024 · NDC 53943-305Full label
- FSA STORE INC.ANDA214039 · Label 01/12/2023 · NDC 81522-205Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing01/14/2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster...SpecGx, LLC · 2 products · Failed Tablet/Capsule Specification: There is a potential for the...
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
- Class IIDrugOngoing11/05/2025TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer...Kenvue Brands LLC · Defective Container
- Class IIDrugOngoing09/03/2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter...Baxter Healthcare Corporation · Discoloration
- Class IIDrugOngoing06/25/2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry...Aurobindo Pharma USA Inc · cGMP deviations: Due to confirmed consumer complaints received...
Migraine Relief: common questions
- What is Migraine Relief used for?
- ■ treats migraine
- Is Migraine Relief a prescription drug?
- No. Migraine Relief is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Migraine Relief?
- Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength.
- Who makes Migraine Relief?
- 5 manufacturers list Migraine Relief with the FDA, including HARRIS TEETER, AAA PHARMACEUTICAL, INC., CHAIN DRUG MARKETING ASSOCIATION, INC.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/05/2026 · Label text is shown as published by the manufacturer. Not medical advice