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Acetaminophen, Aspirin and Caffeine

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Acetaminophen, Aspirin and Caffeine
Generic name
Acetaminophen, Aspirin and Caffeine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Granules India Ltd
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
5
Packages
10
Data completeness
82% 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
15

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@FDANDC 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 HUMAN OTC DRUG · 20251201 HUMAN OTC DRUG · 20251006

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps

PURPOSE Pain reliever Pain reliever Pain reliever aid

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours. children under 12 years: ask a doctor Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) close cap tightly after use read all product information before using.

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: 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

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 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 ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present any new symptoms occur. These could be signs of a serious condition

Active Ingredient

openFDA Drug Labeling

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED Drug Facts Active ingredients (in each caplet) Purposes Acetaminophen USP, 250 mg...............................................................Pain reliever Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever Caffeine USP, 65 mg........................................................................Pain reliever aid *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
55319-680-10 55319-680 FAMILY DOLLAR 100 TABLET in 1 BOTTLE (55319-680-10) September 1, 2023
62207-680-47 62207-680 Granules India Ltd 500 TABLET in 1 BOTTLE (62207-680-47) April 15, 2021
62207-680-51 62207-680 Granules India Ltd 1 BOTTLE in 1 CARTON (62207-680-51) / 10 TABLET in 1 BOTTLE April 15, 2021
62207-680-98 62207-680 Granules India Ltd 22500 TABLET in 1 BOX (62207-680-98) April 15, 2021
62207-680-99 62207-680 Granules India Ltd 4500 TABLET in 1 POUCH (62207-680-99) April 15, 2021
57237-348-01 57237-348 Rising Pharma Holdings, Inc. 100 TABLET in 1 BOTTLE (57237-348-01) July 9, 2025
21130-681-05 21130-681 Safeway, Inc 50 TABLET in 1 BOTTLE (21130-681-05) August 4, 2023
21130-681-10 21130-681 Safeway, Inc 100 TABLET in 1 BOTTLE (21130-681-10) August 4, 2023
21130-681-24 21130-681 Safeway, Inc 24 TABLET in 1 BOTTLE (21130-681-24) August 4, 2023
71309-079-03 71309-079 Safrel Pharmaceuticals, LLC. 300 TABLET in 1 BOTTLE (71309-079-03) April 15, 2021
55319-680 55319-680 FAMILY DOLLAR — September 1, 2023
62207-680 62207-680 Granules India Ltd — April 15, 2021
57237-348 57237-348 Rising Pharma Holdings, Inc. — July 9, 2025
21130-681 21130-681 Safeway, Inc — August 4, 2023
71309-079 71309-079 Safrel Pharmaceuticals, LLC. — April 15, 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.