Migraine Relief
f837e190-6fb3-e22e-e053-6394a90a12e6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever aid
Medication Information
Purpose
Pain reliever Pain reliever aid
Description
Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Pdp
Use
treats migraine
Purposes
Pain reliever
Pain reliever aid
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
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
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
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.
Other Information
• store at controlled room temperature 20° to 25°C (68° to 77°F)
• close cap tightly after use
• read all product information before using.
Keep this box for important information.
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.
Inactive Ingredients:
carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide
Questions Or Comments?
contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
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
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
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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.
Active Ingredients (in Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Medication Overuse Headache Warning:
Headaches may worsen if this product is used for 10 or more days per month.
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
Structured Label Content
Pdp (PDP)
Use
treats migraine
Purposes
Pain reliever
Pain reliever aid
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
Do Not Use (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
Allergy Alert: (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: (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
Caffeine Warning: (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.
Other Information (Other information)
• store at controlled room temperature 20° to 25°C (68° to 77°F)
• close cap tightly after use
• read all product information before using.
Keep this box for important information.
Reye’s Syndrome: (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.
Inactive Ingredients: (Inactive ingredients:)
carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide
Questions Or Comments? (Questions or comments?)
contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Stomach Bleeding Warning: (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
Ask A Doctor Before Use If (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 (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
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If Pregnant Or Breast Feeding, (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.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Medication Overuse Headache Warning: (Medication overuse headache warning:)
Headaches may worsen if this product is used for 10 or more days per month.
Ask A Doctor Or Pharmacist Before Use If You Are (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:50.629694 · Updated: 2026-03-14T23:11:44.718615