Prescription and over-the-counter medicine
Acetaminophen and ibuprofen Brand names: Combogesic
Acetaminophen and ibuprofen (Combogesic) is a prescription and over-the-counter medicine with an FDA approval on record since 2020. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.107 per unit (Gs dual action pain 250-125 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the acetaminophen and ibuprofen FDA label on DailyMed (effective April 21, 2025, Haleon US Holdings LLC); the NDA 211733 record on Drugs@FDA; every acetaminophen and ibuprofen label on DailyMed.
Highlights of the record
FDA label of April 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HEPATOTOXICITY, CARDIOVASCULAR RISK, AND GASTROINTESTINAL RISK WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK AND GASTROINTESTINAL RISK.
See full prescribing information for complete boxed warning.
COMBOGESIC contains acetaminophen, which has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 milligrams per day, and often involve more than one acetaminophen containing product ( 5.1 ).
Nonsteroidal anti-inflammatory drugs (NSAIDS), like the ibuprofen in COMBOGESIC, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use ( 5.2 ).
COMBOGESIC tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 5.2 ).
NSAIDS, like the ibuprofen in COMBOGESIC, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.3 ). […]
This box is printed on the prescription label of acetaminophen and ibuprofen; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usagetemporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis
Forms and strengths
- 125 mg / 250 mg
- 250 mg / 125 mg
- 325 mg / 97.5 mg
- 1000 mg/100ml / 300 mg/100ml
Film-coated tablet; tablet; capsule; injection.
On the market
- Earliest approval on file
- February 28, 2020 Advil Dual Action With Acetaminophen, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first February 28, 2023; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 56 of which 47 under generic applications, 9 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- July 9, 2041 Advil Dual Action With Acetaminophen tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.107 per unit Gs dual action pain 250-125 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 3,149 through July 30, 2026
What is acetaminophen and ibuprofen used for?
From the label: indications and usagetemporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis
Conditions named in the indications of acetaminophen and ibuprofen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (ADVIL DUAL ACTION WITH ACETAMINOPHEN), Haleon US Holdings LLC, effective April 21, 2025 (SPL set f5ea858e-76d9-4777-b3dc-5d614f66d485), via openFDA; the full label on DailyMed
What does the patient leaflet for acetaminophen and ibuprofen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about COMBOGESIC?COMBOGESIC may cause serious side effects, including: • Severe liver problems. Acetaminophen, one of the ingredients in COMBOGESIC, has caused severe and life-threatening acute liver failure which caused the need for a liver transplant and has caused death. o Taking COMBOGESIC with other products that contain acetaminophen can lead to serious severe liver problems and death. Do not take COMBOGESIC with other acetaminophen containing products. o You should not take more than 3 COMBOGESIC tablets in one dose or more than 12 COMBOGESIC tablets in one day. o If you take too much COMBOGESIC or acetaminophen, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away. • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase :Do not take COMBOGESIC right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking COMBOGESIC after a recent heart attack unless your healthcare provider tells you to. […]
From the patient leaflet: What should I avoid while taking COMBOGESIC?You should avoid drinking alcohol during treatment with COMBOGESIC. Drinking alcohol during treatment with COMBOGESIC may increase your chances of having serious side effects.
Source: FDA drug label (Combogesic), Preferred Pharmaceuticals Inc., effective August 20, 2026 (SPL set f3cee991-19ef-4a1c-bb14-cbc8b6f32776), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and ibuprofen (Combogesic)?
The FDA approved the first generic acetaminophen and ibuprofen on February 28, 2023. 10 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and ibuprofen from 47 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Advil Dual Action With Acetaminophen tablets, the last expiring on July 9, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2023 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and ibuprofen (Combogesic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.107 per unit (Gs dual action pain 250-125 mg), up 20% from $0.0892 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dual action pain 250-125 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acetamin-ibuprofn 250-125 mg tablet | Generic | $0.107 per tablet | $3.21 | n/a |
| Dual action pain 250-125 mg | Generic | $0.107 per unit | n/a | +20% |
| Ft dual action pain 250-125 mg | Generic | $0.107 per unit | n/a | +20% |
| Gnp acetaminophen-ibuprofen 250-125 mg tablet | Generic | $0.107 per tablet | $3.21 | +20% |
| Gnp dual action pain 250-125 mg | Generic | $0.107 per unit | n/a | +20% |
| Gs dual action pain 250-125 mg | Generic | $0.107 per unit | n/a | +20% |
| Qc dual action pain 250-125 mg | Generic | $0.107 per unit | n/a | +20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetaminophen and ibuprofen been recalled?
The FDA's Enforcement Report lists 1 recall naming acetaminophen and ibuprofen since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetaminophen and ibuprofen label say about other medicines?
The acetaminophen and ibuprofen label names 15 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications (prescription label) | • patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDS [see Warnings and Precautions (5.7 and 5.8) ]. |
| Cyclosporine | drug interactions (prescription label) | Clinical Impact: Concomitant use of NSAIDS and cyclosporine may increase cyclosporine's nephrotoxicity. Intervention: During concomitant use of COMBOGESIC and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions (prescription label) | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions (prescription label) | NSAIDs and Salicylates Clinical Impact: Concomitant use of ibuprofen with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy [ see ]. Intervention: The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions (prescription label) | Clinical Impact: The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of COMBOGESIC and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions (prescription label) | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of COMBOGESIC with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see and ]. |
| Indomethacin | drug interactions (prescription label) | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions (prescription label) | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of COMBOGESIC and lithium, monitor patients for signs of lithium toxicity. |
| Meloxicam | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of NSAIDS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions (prescription label) | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of COMBOGESIC and methotrexate, monitor patients for methotrexate toxicity. |
| Nabumetone | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of NSAIDS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Naproxen | warnings | take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] |
| Pemetrexed | drug interactions (prescription label) | Pemetrexed Clinical Impact: Concomitant use of NSAIDS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of COMBOGESIC and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Propranolol | drug interactions (prescription label) | ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). … Intervention: • During concomitant use of COMBOGESIC and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
Every other medicine the acetaminophen and ibuprofen label names
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions (prescription label) | Drugs That Interfere with Hemostasis Clinical Impact: • Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. … Intervention: Monitor patients with concomitant use of COMBOGESIC with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine … |
Source: FDA drug label (ADVIL DUAL ACTION WITH ACETAMINOPHEN), Haleon US Holdings LLC, effective April 21, 2025 (SPL set f5ea858e-76d9-4777-b3dc-5d614f66d485), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and ibuprofen?
The FDA Adverse Event Reporting System holds 3,149 reports that list acetaminophen and ibuprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 60 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,375, against a median of 84 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acetaminophen and ibuprofen?
33 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and ibuprofen or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naproxen | Pain | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Pain | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Ketorolac | Pain | 33 labelers | $0.164 per tablet 10 mg tablet | In shortage |
| Fenoprofen | Pain | 6 labelers | n/a | No current entry |
| Diflunisal | Pain | 6 labelers | $1.06 per tablet 500 mg tablet | No current entry |
Every medicine labeled for the same conditions as acetaminophen and ibuprofen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acetaminophen and ibuprofen
- 33 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Acetaminophen and ibuprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other