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DUAL ACTION
Acetaminophen, Ibuprofen · Tablet, Film Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 214836-001 | ACETAMINOPHEN AND IBUPROFEN | TABLET | ACETAMINOPHEN; IBUPROFEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 5 | Labeling | Approved | October 22, 2025 | Standard |
| Supplement | 3 | Labeling | Approved | October 22, 2025 | Standard |
| Supplement | 2 | Labeling | Approved | October 22, 2025 | Standard |
| Original application | 1 | Approved | February 28, 2023 | Standard |
Review documents
- 0 · Original application · March 14, 2023
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260909). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses Uses • temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis
Purpose
openFDA Drug LabelingPurposes Pain Reliever Pain Reliever
Dosage and Administration
openFDA Drug LabelingDirections 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 LabelingWarnings 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 (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.
Do Not Use
openFDA Drug LabelingDo 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 LabelingAsk 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 LabelingStop 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 LabelingActive ingredients (in each caplet) Acetaminophen USP, 250 mg Ibuprofen USP, 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 72288-542-01 | 72288-542 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-542-01) / 216 TABLET, FILM COATED in 1 BOTTLE (72288-542-00) | May 18, 2026 |
| 75907-158-14 | 75907-158 | Dr. Reddy's Laboratories Inc | 144 TABLET, FILM COATED in 1 BOTTLE (75907-158-14) | February 6, 2025 |
| 75907-158-25 | 75907-158 | Dr. Reddy's Laboratories Inc | 250 TABLET, FILM COATED in 1 BOTTLE (75907-158-25) | February 6, 2025 |
| 42507-540-72 | 42507-540 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-540-72) / 72 TABLET, FILM COATED in 1 BOTTLE (42507-540-23) | March 18, 2026 |
| 56062-530-23 | 56062-530 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-530-23) / 72 TABLET, FILM COATED in 1 BOTTLE | May 16, 2025 |
| 56062-530-68 | 56062-530 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-530-68) / 36 TABLET, FILM COATED in 1 BOTTLE | May 16, 2025 |
| 11822-5777-0 | 11822-5777 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-5777-0) / 36 TABLET, FILM COATED in 1 BOTTLE | May 24, 2023 |
| 11822-5777-1 | 11822-5777 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-5777-1) / 72 TABLET, FILM COATED in 1 BOTTLE | May 24, 2023 |
| 11822-5777-2 | 11822-5777 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-5777-2) / 18 TABLET, FILM COATED in 1 BOTTLE | May 24, 2023 |
| 72288-542 | 72288-542 | Amazon.com Services LLC | — | May 18, 2026 |
| 75907-158 | 75907-158 | Dr. Reddy's Laboratories Inc | — | February 6, 2025 |
| 42507-540 | 42507-540 | HyVee Inc | — | March 18, 2026 |
| 56062-530 | 56062-530 | Publix Super Markets Inc | — | May 16, 2025 |
| 11822-5777 | 11822-5777 | Rite Aid Corporation | — | May 24, 2023 |
Sources for 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.