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Acetaminophen, Aspirin and Caffeine

Acetaminophen, Aspirin and Caffeine is a central nervous system stimulant (over-the-counter), made by 8 manufacturers.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
8

Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

Drug facts

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
Capsule, Tablet, Tablet, film coated
Label holder
Softgel Healthcare Pvt Ltd
FDA application
M013
Label updated
04/27/2026

Active ingredients

(in each geltab) Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever Pain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

  • Headache
  • A cold
  • Arthritis
  • Muscular aches
  • Toothache
  • Premenstrual and menstrual cramps

Directions

  • Do not use more than directed (see overdose warning)
  • Drink a full glass of water with each dose
  • Adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours
  • Children under 12 years: 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 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 8 geltabs 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 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 occasional 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 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

Ask a doctor or pharmacist before use

Taking

  • A prescription drug for diabetes, gout, or arthritis
  • Any other drug, or are under a doctor's care for any serious condition

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
  • Ringing in the ears or loss of hearing occurs
  • Painful area is red or swollen
  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days
  • Any new symptoms occur These could be signs of a serious condition.

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

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Inactive ingredients

Corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized potato starch, purified water, pvpk-30, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin.

Forms and strengths

From the FDA NDC Directory · 9 product codes

Dosage formStrengthRouteNDCs
Capsule250 mg / 250 mg / 65 mgoral1
Tablet250 mg / 250 mg / 65 mgoral3
Tablet250 mg / 65 mg / 250 mgoral1
Tablet, film coated250 mg / 250 mg / 65 mgoral4

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

9 FDA labels

  • Softgel Healthcare Pvt LtdShown hereM013 · Label 04/27/2026 · NDC 35916-0709Full label
  • Aurohealth LLCANDA211695 · Label 12/01/2023 · NDC 58602-882Full label
  • Aurohealth LLCANDA211695 · Label 05/11/2023 · NDC 58602-817Full label
  • Better Living Brands, LLCANDA211695 · Label 08/17/2023 · NDC 21130-074Full label
  • FAMILY DOLLARANDA214039 · Label 12/19/2025 · NDC 55319-680Full label
  • Rising Pharma Holdings, Inc.M013 · Label 10/06/2025 · NDC 57237-348Full label
  • Safeway, IncANDA214039 · Label 12/19/2025 · NDC 21130-681Full label
  • Safrel Pharmaceuticals, LLC.ANDA214039 · Label 11/22/2023 · NDC 71309-079Full label
  • WALMART INC.ANDA211695 · Label 03/05/2024 · NDC 79903-216Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Acetaminophen, Aspirin and Caffeine: common questions

What is Acetaminophen, Aspirin and Caffeine used for?
Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps
Is Acetaminophen, Aspirin and Caffeine a prescription drug?
No. Acetaminophen, Aspirin and Caffeine is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Acetaminophen, Aspirin and Caffeine?
Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Headache Relief Extra Strength, Migraine Relief.
Who makes Acetaminophen, Aspirin and Caffeine?
8 manufacturers list Acetaminophen, Aspirin and Caffeine with the FDA, including Softgel Healthcare Pvt Ltd, Aurohealth LLC, Better Living Brands, LLC.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/27/2026 · Label text is shown as published by the manufacturer. Not medical advice