ACETAMINOPHEN ASPIRIN AND CAFFEINE — Tablet, Film Coated

Overview

Brand name

ACETAMINOPHEN ASPIRIN AND CAFFEINE

Generic name

acetaminophen, aspirin and caffeine

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Aurohealth LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

3

NDC product codes

4

Packages

16

Data completeness

77% 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, Film Coated

Route of administration

Oral

Presentations

20

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

211695

Application type

ANDA · Abbreviated New Drug Application

Approval date

February 2, 2022

Sponsor

AUROBINDO PHARMA LTD

Products on application

1

Submissions recorded

1

Products approved under application 211695.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	TABLET		ACETAMINOPHEN; ASPIRIN; CAFFEINE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 211695.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	February 2, 2022	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20230511). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20230511

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 tablets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 tablets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor

Warnings

openFDA Drug Labeling

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 tablets 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 • 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

Drug Facts Active ingredients (in each tablet) Acetaminophen USP 250 mg Aspirin USP 250 mg (NSAID*) Caffeine USP 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.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class I	August 28, 2024	Aurobindo Pharma USA Inc	Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.	Ongoing

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
58602-817-02	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-02) / 8 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-03	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-03) / 10 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-07	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-07) / 24 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-09	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-09) / 30 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-14	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-14) / 50 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-21	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-21) / 100 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-817-34	58602-817	Aurohealth LLC	200 TABLET, FILM COATED in 1 BOTTLE (58602-817-34)	February 2, 2022
58602-817-36	58602-817	Aurohealth LLC	250 TABLET, FILM COATED in 1 BOTTLE (58602-817-36)	February 2, 2022
58602-817-38	58602-817	Aurohealth LLC	300 TABLET, FILM COATED in 1 BOTTLE (58602-817-38)	February 2, 2022
58602-817-90	58602-817	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-817-90) / 125 TABLET, FILM COATED in 1 BOTTLE	February 2, 2022
58602-882-21	58602-882	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-882-21) / 100 TABLET, FILM COATED in 1 BOTTLE	June 23, 2022
58602-882-38	58602-882	Aurohealth LLC	1 BOTTLE in 1 CARTON (58602-882-38) / 300 TABLET, FILM COATED in 1 BOTTLE	June 23, 2022
21130-074-07	21130-074	Better Living Brands, LLC	1 BOTTLE in 1 CARTON (21130-074-07) / 24 TABLET, FILM COATED in 1 BOTTLE	August 11, 2023
21130-074-14	21130-074	Better Living Brands, LLC	1 BOTTLE in 1 CARTON (21130-074-14) / 50 TABLET, FILM COATED in 1 BOTTLE	August 11, 2023
21130-074-21	21130-074	Better Living Brands, LLC	1 BOTTLE in 1 CARTON (21130-074-21) / 100 TABLET, FILM COATED in 1 BOTTLE	August 11, 2023
79903-216-10	79903-216	WALMART INC.	1 BOTTLE in 1 CARTON (79903-216-10) / 100 TABLET, FILM COATED in 1 BOTTLE	February 28, 2024
58602-817	58602-817	Aurohealth LLC	—	February 2, 2022
58602-882	58602-882	Aurohealth LLC	—	June 23, 2022
21130-074	21130-074	Better Living Brands, LLC	—	August 11, 2023
79903-216	79903-216	WALMART INC.	—	February 28, 2024

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
Enforcement	FDA	Recall records

Generated September 25, 2026 · 11 sections on this page.