Acetaminophen Aspirin Caffeine — Tablet

Overview

Brand name

Acetaminophen Aspirin Caffeine

Generic name

Acetaminophen Aspirin Caffeine

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

CVS PHARMACY, INC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

3

NDC product codes

2

Packages

2

Data completeness

76% 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
Aspirin	250 mg/1	994535	View
Caffeine	65 mg/1	994535	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

4

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
Anti-Inflammatory Agents	EPC	All 251 members
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
Methylxanthine [EPC]	EPC	All 30 members
Non-Steroidal [CS]	CS	All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC]	EPC	All 251 members
Platelet Aggregation Inhibitor [EPC]	EPC	All 29 members
Xanthines [CS]	CS	All 30 members

Regulatory status

Source: Drugs@FDA NDC 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 20251219). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251219

Indications and Usage

openFDA Drug Labeling

Use treats migraine

Purpose

openFDA Drug Labeling

Purposes Pain reliever Pain reliever Pain reliever aid

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS

679,519

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

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
69842-680-10	69842-680	CVS PHARMACY, INC	100 TABLET in 1 BOTTLE (69842-680-10)	July 5, 2021
0363-9680-24	0363-9680	WALGREEN CO	24 TABLET in 1 BOTTLE (0363-9680-24)	August 16, 2021
69842-680	69842-680	CVS PHARMACY, INC	—	July 5, 2021
0363-9680	0363-9680	WALGREEN CO	—	August 16, 2021

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
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.