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ADVIL DUAL ACTION WITH ACETAMINOPHEN

Ibuprofen, Acetaminophen · Tablet, Film Coated

Over-the-counter NDA RLD 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
ADVIL DUAL ACTION WITH ACETAMINOPHEN
Generic name
Ibuprofen, Acetaminophen
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
5
Packages
26
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
Ibuprofen 125 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
31

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
211733
Application type
NDA · New Drug Application
Approval date
February 28, 2020
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
4
Products approved under application 211733.
Product Trade name Form Strength Ingredient Status TE Flags
211733-001 ADVIL DUAL ACTION WITH ACETAMINOPHEN TABLET ACETAMINOPHEN; IBUPROFEN Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
11918693 July 9, 2041 001 No March 26, 2024

Approval history

Source: Drugs@FDA
Most recent submissions on application 211733.
Type No. Action Status Date Review
Supplement 7 Labeling Approved May 5, 2025 Standard
Supplement 4 Labeling Approved January 25, 2022 Standard
Supplement 3 Labeling Approved January 10, 2022 Standard
Original application 1 Type 4 - New Combination Approved February 28, 2020 Standard

Review documents

  • 0 · Supplement · June 2, 2025
  • 0 · Supplement · May 8, 2025
  • 0 · Supplement · February 3, 2022
  • 0 · Supplement · January 27, 2022
  • 0 · Supplement · January 11, 2022
  • 0 · Supplement · January 11, 2022
  • 0 · Original application · March 31, 2020
  • 0 · Original application · February 28, 2020
  • 0 · Original application · February 28, 2020

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240424). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240424 HUMAN OTC DRUG · 20240415

Indications and Usage

openFDA Drug Labeling

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

Active ingredients (in each caplet) Purposes Acetaminophen 250 mg Pain reliever Ibuprofen 125 mg (NSAID nonsteroidal anti-inflammatory drug ) 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 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) Purposes Acetaminophen 250 mg Pain reliever Ibuprofen 125 mg (NSAID nonsteroidal anti-inflammatory drug ) Pain reliever

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
0573-0145-02 0573-0145 Haleon US Holdings LLC 2 TABLET, FILM COATED in 1 POUCH (0573-0145-02) January 16, 2023
0573-0145-18 0573-0145 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE January 16, 2023
0573-0145-72 0573-0145 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0145-72) / 72 TABLET, FILM COATED in 1 BOTTLE January 16, 2023
0573-0145-89 0573-0145 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0145-89) / 144 TABLET, FILM COATED in 1 BOTTLE January 16, 2023
0573-0145-99 0573-0145 Haleon US Holdings LLC 3000 POUCH in 1 CASE (0573-0145-99) / 2 TABLET, FILM COATED in 1 POUCH January 16, 2023
0573-0147-09 0573-0147 Haleon US Holdings LLC 8 TABLET, FILM COATED in 1 BOTTLE (0573-0147-09) May 15, 2023
0573-0147-18 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-18) / 18 TABLET, FILM COATED in 1 BOTTLE July 27, 2020
0573-0147-24 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-24) / 24 TABLET, FILM COATED in 1 BOTTLE September 6, 2021
0573-0147-36 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-36) / 36 TABLET, FILM COATED in 1 BOTTLE July 27, 2020
0573-0147-72 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-72) / 72 TABLET, FILM COATED in 1 BOTTLE July 27, 2020
0573-0147-86 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-86) / 216 TABLET, FILM COATED in 1 BOTTLE July 27, 2020
0573-0147-90 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-90) / 90 TABLET, FILM COATED in 1 BOTTLE April 8, 2024
0573-0147-91 0573-0147 Haleon US Holdings LLC 3000 POUCH in 1 CASE (0573-0147-91) / 2 TABLET, FILM COATED in 1 POUCH May 15, 2023
0573-0147-93 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-93) / 162 TABLET, FILM COATED in 1 BOTTLE April 9, 2024
0573-0147-94 0573-0147 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0147-94) / 144 TABLET, FILM COATED in 1 BOTTLE July 27, 2020
0573-0147-95 0573-0147 Haleon US Holdings LLC 50 POUCH in 1 CARTON (0573-0147-95) / 2 TABLET, FILM COATED in 1 POUCH July 27, 2020
0573-0147-97 0573-0147 Haleon US Holdings LLC 240 TABLET, FILM COATED in 1 BOTTLE (0573-0147-97) March 15, 2025
66715-9601-2 66715-9601 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-9601-2) / 2 TABLET, FILM COATED in 1 POUCH January 7, 2025
66715-9601-3 66715-9601 Lil' Drug Store Products, Inc. 3 POUCH in 1 CARTON (66715-9601-3) / 2 TABLET, FILM COATED in 1 POUCH May 17, 2023
67751-211-01 67751-211 Navajo Manufacturing Company Inc. 1 POUCH in 1 CARTON (67751-211-01) / 2 TABLET, FILM COATED in 1 POUCH May 21, 2021
67751-211-02 67751-211 Navajo Manufacturing Company Inc. 2 POUCH in 1 CARTON (67751-211-02) / 2 TABLET, FILM COATED in 1 POUCH May 21, 2021
85237-1886-1 85237-1886 Select Consumer Group 1 POUCH in 1 BLISTER PACK (85237-1886-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0) April 9, 2024
85237-1886-2 85237-1886 Select Consumer Group 2 POUCH in 1 BLISTER PACK (85237-1886-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0) April 9, 2024
85237-1886-4 85237-1886 Select Consumer Group 25 POUCH in 1 CARTON (85237-1886-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0) April 9, 2024
85237-1886-6 85237-1886 Select Consumer Group 50 POUCH in 1 CARTON (85237-1886-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0) April 9, 2024
85237-1886-7 85237-1886 Select Consumer Group 3 POUCH in 1 BLISTER PACK (85237-1886-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0) April 9, 2024
0573-0145 0573-0145 Haleon US Holdings LLC — January 16, 2023
0573-0147 0573-0147 Haleon US Holdings LLC — July 27, 2020
66715-9601 66715-9601 Lil' Drug Store Products, Inc. — May 17, 2023
67751-211 67751-211 Navajo Manufacturing Company Inc. — May 21, 2021
85237-1886 85237-1886 Select Consumer Group — July 27, 2020

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.