Acetaminophen and Ibuprofen (NSAID)

Overview

Brand name

Acetaminophen and Ibuprofen (NSAID)

Generic name

Acetaminophen and Ibuprofen (NSAID)

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

RITE AID

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

3

Packages

5

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
Ibuprofen	125 mg/1	310965	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

8

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
Cyclooxygenase Inhibitors [MoA]	MoA	All 251 members
Non-Steroidal [CS]	CS	All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC]	EPC	All 251 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

216592

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 13, 2023

Sponsor

GRANULES

Products on application

1

Submissions recorded

4

Products approved under application 216592.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
216592-001	ACETAMINOPHEN AND IBUPROFEN	TABLET		ACETAMINOPHEN; IBUPROFEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 216592.
Type	No.	Action	Status	Date	Review
Supplement	8	Labeling	Approved	December 17, 2025	Standard
Supplement	6	Labeling	Approved	October 1, 2025	Standard
Supplement	2	Labeling	Approved	March 27, 2024	Standard
Original application	1		Approved	July 13, 2023	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

Indications and Usage

openFDA Drug Labeling

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Purpose

openFDA Drug Labeling

Purposes Pain reliever Pain reliever

Dosage and Administration

openFDA Drug Labeling

Directions ■ do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

Warnings

openFDA Drug Labeling

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 6 caplets in 24 hours, which is the maximum daily amount for this product ■ 3 or more alcoholic drinks every day while using this product

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away.

NSAID 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

openFDA Drug Labeling

Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ if you have ever had an allergic reaction to acetaminophen or any other pain reliever ■ right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if ■ you have liver disease ■ stomach bleeding warning applies to you ■ you have problems or serious side effects from taking pain relievers ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you are taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if ■ 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 ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts more than 10 days ■ redness or swelling is present in the painful area ■ any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID**) **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
72476-131-72	72476-131	RETAIL BUSINESS SERVICES,LLC	72 TABLET in 1 BOTTLE (72476-131-72)	July 20, 2023
72476-131-81	72476-131	RETAIL BUSINESS SERVICES,LLC	18 TABLET in 1 BOTTLE (72476-131-81)	July 20, 2023
11822-1131-4	11822-1131	RITE AID	144 TABLET in 1 BOTTLE (11822-1131-4)	July 21, 2023
11822-1131-6	11822-1131	RITE AID	216 TABLET in 1 BOTTLE (11822-1131-6)	July 21, 2023
79903-931-44	79903-931	Wal-Mart Stores Inc.	144 TABLET in 1 BOTTLE (79903-931-44)	July 18, 2023
72476-131	72476-131	RETAIL BUSINESS SERVICES,LLC	—	July 20, 2023
11822-1131	11822-1131	RITE AID	—	July 21, 2023
79903-931	79903-931	Wal-Mart Stores Inc.	—	July 18, 2023

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.