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Acetaminophen Aspirin Caffeine

Acetaminophen Aspirin Caffeine is a central nervous system stimulant (over-the-counter), made by 4 manufacturers.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
4
+ 2 repackager labels

treats migraine

Drug facts

Name
Acetaminophen Aspirin 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, Tablet, film coated
Label holder
WALGREEN CO
FDA application
ANDA214039
Label updated
12/19/2025

Active ingredients

(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)** Caffeine 65 mg **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever Pain reliever 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 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 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

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

Pregnancy or breastfeeding

Ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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. 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 room temperature 20° to 25°C (68° to 77°F)
  • Close cap tightly after use
  • Read all product information before using.

Inactive ingredients

Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide

Questions?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Forms and strengths

From the FDA NDC Directory · 6 product codes

Dosage formStrengthRouteNDCs
Tablet250 mg / 65 mg / 250 mgoral2
Tablet, film coated65 mg / 250 mg / 250 mgoral1
Tablet, film coated250 mg / 250 mg / 65 mgoral1
Tablet, film coated250 mg / 65 mg / 250 mgoral2

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $0.0633 per tablet, capsule or unit across 1 package code.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Manufacturers and labels

6 FDA labels · 2 from repackagers

  • WALGREEN COShown hereANDA214039 · Label 12/19/2025 · NDC 0363-9680Full label
  • CVS PHARMACY, INCANDA214039 · Label 12/19/2025 · NDC 69842-680Full label
  • CVS Pharmacy, Inc.M013 · Label 10/21/2025 · NDC 69842-541Full label
  • LEADER/ Cardinal Health 110, Inc.M013 · Label 02/11/2025 · NDC 70000-0066Full label
Repackager labels (2)
  • NuCare Pharmaceuticals,Inc.11/13/2025
  • Proficient Rx LP11/01/2023

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Acetaminophen Aspirin Caffeine: common questions

What is Acetaminophen Aspirin Caffeine used for?
treats migraine
Is Acetaminophen Aspirin Caffeine a prescription drug?
No. Acetaminophen Aspirin Caffeine is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Acetaminophen Aspirin Caffeine?
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 Acetaminophen Aspirin Caffeine?
4 manufacturers list Acetaminophen Aspirin Caffeine with the FDA, including WALGREEN CO, CVS PHARMACY, INC, CVS Pharmacy, Inc.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/19/2025 · Label text is shown as published by the manufacturer. Not medical advice