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Acetaminophen and Ibuprofen

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 and Ibuprofen
Generic name
Acetaminophen and Ibuprofen
Dosage form
Tablet
Route
—
Marketing category
ANDA · ANDA
Labeler
CVS
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
10
Packages
18
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 1 mg/1 313782 View
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
—
Presentations
28

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@FDANDC 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 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251219 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

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 hour s 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 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 • 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 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 Ask a doctor or pharmacist before use if you are • under a doctor's care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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. 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 for children even if you do not notice any signs or symptoms.

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 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

Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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
51316-131-36 51316-131 CVS 36 TABLET in 1 BOTTLE (51316-131-36) October 1, 2023
51316-131-44 51316-131 CVS 144 TABLET in 1 BOTTLE (51316-131-44) October 1, 2023
51316-131-72 51316-131 CVS 72 TABLET in 1 BOTTLE (51316-131-72) October 1, 2023
51316-132-72 51316-132 CVS 72 TABLET in 1 BOTTLE (51316-132-72) October 6, 2023
51316-132-81 51316-132 CVS 18 TABLET in 1 BOTTLE (51316-132-81) October 6, 2023
51316-401-72 51316-401 CVS 72 TABLET in 1 BOTTLE (51316-401-72) July 1, 2025
51316-401-81 51316-401 CVS 18 TABLET in 1 BOTTLE (51316-401-81) July 1, 2025
55319-139-36 55319-139 Family Dollar 36 TABLET in 1 BOTTLE (55319-139-36) November 1, 2023
62207-588-32 62207-588 Granules India Limited 10000 TABLET in 1 DRUM (62207-588-32) August 30, 2023
62207-588-85 62207-588 Granules India Limited 90000 TABLET in 1 DRUM (62207-588-85) March 1, 2024
70010-131-26 70010-131 Granules Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (70010-131-26) / 18 TABLET in 1 BOTTLE July 24, 2023
70010-131-31 70010-131 Granules Pharmaceuticals Inc. 288 TABLET in 1 BOTTLE (70010-131-31) July 24, 2023
70000-0622-1 70000-0622 LEADER/ Cardinal Health 110, Inc. 18 TABLET in 1 BOTTLE (70000-0622-1) July 15, 2023
70000-0622-2 70000-0622 LEADER/ Cardinal Health 110, Inc. 36 TABLET in 1 BOTTLE (70000-0622-2) July 15, 2023
0536-1376-36 0536-1376 RUGBY LABORATORIES 36 TABLET in 1 BOTTLE (0536-1376-36) July 15, 2023
79903-244-44 79903-244 WAL-MART STORES INC. 144 TABLET in 1 BOTTLE (79903-244-44) February 5, 2024
0363-9131-16 0363-9131 WALGREENS 216 TABLET in 1 BOTTLE (0363-9131-16) July 19, 2023
0363-9131-44 0363-9131 WALGREENS 144 TABLET in 1 BOTTLE (0363-9131-44) July 19, 2023
51316-131 51316-131 CVS — October 1, 2023
51316-132 51316-132 CVS — October 6, 2023
51316-401 51316-401 CVS — July 1, 2025
55319-139 55319-139 Family Dollar — November 1, 2023
62207-588 62207-588 Granules India Limited — August 30, 2023
70010-131 70010-131 Granules Pharmaceuticals Inc. — July 24, 2023
70000-0622 70000-0622 LEADER/ Cardinal Health 110, Inc. — July 15, 2023
0536-1376 0536-1376 RUGBY LABORATORIES — July 15, 2023
79903-244 79903-244 WAL-MART STORES INC. — February 5, 2024
0363-9131 0363-9131 WALGREENS — July 19, 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 · 11 sections on this page.