Acetaminophen and Ibuprofen (Combogesic prescription tablets)
Generic name: acetaminophen and ibuprofen · Brand names: Combogesic (Rx tablets, 325 mg/97.5 mg)
Quick facts
Drug class
Combogesic combines acetaminophen with ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID).
Section
Highlights, Indications and Usage (COMBOGESIC label)
Source text (exact source wording)
COMBOGESIC is a combination of acetaminophen and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and is indicated in adults for the short term management of mild to moderate acute pain (1).
Rx or otc
Rx (COMBOGESIC; OTC acetaminophen-ibuprofen products are separate labels and not covered)
Controlled schedule
Not a controlled substance (no schedule shown in the label)
Forms and strengths
- Film-coated tablet containing 325 mg acetaminophen and 97.5 mg ibuprofen (this record's only form)
Generic available
Source
DailyMed list API title search (titles only)
Common use one line
Short-term pain relief for adults with mild to moderate acute pain.
What it is used for
Combogesic is for adults for the short-term management of mild to moderate acute pain.
Section
1 INDICATIONS AND USAGE
Source text (exact source wording)
COMBOGESIC is indicated in adults for the short-term management of mild to moderate acute pain.
How it works
Section
12.1 Mechanism of Action
Dosage: adults
The recommended dose is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day. Use the lowest effective dose for the shortest time, do not exceed the recommended dose in 24 hours, and do not take it with other acetaminophen- or NSAID-containing products.
Section
2 DOSAGE AND ADMINISTRATION
Source text (exact source wording)
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
Do not exceed the recommended dose of COMBOGESIC in 24 hours [see (2) below].
Do not co-administer COMBOGESIC with other acetaminophen- or NSAID-containing products [see Warnings and Precautions (5.1, 5.2, 5.3)].
The recommended dose of COMBOGESIC is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day.
Do not exceed the recommended dose of COMBOGESIC in 24 hours [see (2) below].
Do not co-administer COMBOGESIC with other acetaminophen- or NSAID-containing products [see Warnings and Precautions (5.1, 5.2, 5.3)].
The recommended dose of COMBOGESIC is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day.
Dosage: children
Safety and effectiveness in children have not been established, and Combogesic is not approved for patients under 18 years of age.
Section
8.4 Pediatric Use
Source text (exact source wording)
The safety and effectiveness of COMBOGESIC in pediatric patients have not been established. COMBOGESIC is not approved for patients under 18 years of age.
Dosage adjustments
Kidney
Combogesic has not been studied in people with impaired kidney function, and its use in them is not recommended.
Section
8.6 Use in Renal Disease
Source text (exact source wording)
COMBOGESIC has not been studied in patients with impaired renal function. The use of COMBOGESIC in patients with renal impairment is not recommended [see Warnings and Precautions (5.6)].
Liver
Combogesic has not been studied in people with impaired liver function, and its use in them is not recommended.
Section
5.1 Hepatotoxicity
Source text (exact source wording)
COMBOGESIC has not been studied in patients with impaired hepatic function. The use of COMBOGESIC in patients with hepatic impairment is not recommended.
Elderly
Older people are at greater risk of serious heart, stomach and intestine, and kidney problems from NSAIDs. If the benefit outweighs the risk, start at the low end of the dosing range and monitor for side effects.
Section
8.5 Geriatric Use
Source text (exact source wording)
Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)].
Overdose
Seek medical attention immediately after taking more than 4,000 milligrams of acetaminophen in a day, even if you feel well. Poison control: 1-800-222-1222.
Storage
Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F). Protect from moisture and light.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (AFT Pharmaceuticals label; storage details are labeler-specific)
Source text (exact source wording)
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted within USP controlled room temperature of 15°C to 30°C (59°F to 86°F). Protect from moisture and light.
Boxed warning
Section
BOXED WARNING (AFT Pharmaceuticals label)
Source text (exact source wording)
WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, AND GASTROINTESTINAL RISK
HEPATOTOXICITY
COMBOGESIC contains acetaminophen. Acetaminophen 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 the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1)].
CARDIOVASCULAR RISK
COMBOGESIC contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs 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 [see Warnings and Precautions (5.2)].
COMBOGESIC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)].
GASTROINTESTINAL RISK
NSAIDS 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 [see Warnings and Precautions (5.3)].
HEPATOTOXICITY
COMBOGESIC contains acetaminophen. Acetaminophen 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 the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1)].
CARDIOVASCULAR RISK
COMBOGESIC contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs 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 [see Warnings and Precautions (5.2)].
COMBOGESIC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)].
GASTROINTESTINAL RISK
NSAIDS 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 [see Warnings and Precautions (5.3)].
Contraindications
Do not use Combogesic if you have a known allergy (for example anaphylaxis or serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs or any ingredient, if you have had asthma, hives or other allergic-type reactions after aspirin or other NSAIDs, or in the setting of coronary artery bypass graft (CABG) surgery.
Section
4 CONTRAINDICATIONS
Source text (exact source wording)
COMBOGESIC is contraindicated in:
patients with a known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product [see Warnings and Precautions (5.7, 5.8, 5.9)].
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)].
the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)].
patients with a known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product [see Warnings and Precautions (5.7, 5.8, 5.9)].
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)].
the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)].
Warnings and precautions
Acetaminophen can cause acute liver failure, mostly at doses that exceed 4,000 milligrams per day. The risk is higher in people with liver disease and in people who drink alcohol while taking acetaminophen. Look for acetaminophen or APAP on labels and use only one such product.
Heading
5.1 Hepatotoxicity
Source text (exact source wording)
COMBOGESIC contains acetaminophen. Acetaminophen 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 the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involved more than one acetaminophen-containing product.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.
NSAIDs increase the risk of serious heart attack and stroke, which can be fatal. Combogesic should be avoided in people with a recent heart attack unless the benefits are expected to outweigh the risk.
Heading
5.2 Cardiovascular Thrombotic Events
Source text (exact source wording)
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. ... Avoid the use of COMBOGESIC in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If COMBOGESIC is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
NSAIDs can cause serious bleeding, ulcers and holes in the esophagus, stomach or intestines, which can be fatal and can happen with or without warning symptoms.
Heading
5.3 Gastrointestinal Bleeding, Ulceration, and Perforation
Source text (exact source wording)
NSAIDs, including the ibuprofen in COMBOGESIC tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic.
NSAIDs can cause new high blood pressure or worsen it, and can weaken the effect of ACE inhibitors and diuretics. Blood pressure should be monitored.
Heading
5.4 Hypertension
Source text (exact source wording)
NSAIDs, including the ibuprofen in COMBOGESIC, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
Avoid Combogesic in people with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
Heading
5.5 Heart Failure and Edema
Source text (exact source wording)
Avoid the use of COMBOGESIC in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If COMBOGESIC is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Long-term NSAID use has resulted in kidney injury, including renal papillary necrosis.
Heading
5.6 Renal Toxicity and Hyperkalemia
Source text (exact source wording)
Long-term administration of NSAIDs, including the ibuprofen component of COMBOGESIC, has resulted in renal papillary necrosis and other renal injury.
Stop Combogesic immediately and seek emergency care for symptoms of a severe allergic reaction. It should not be prescribed to people allergic to acetaminophen.
Heading
5.7 Anaphylaxis and Other Hypersensitivity Reactions
Source text (exact source wording)
Instruct patients to discontinue COMBOGESIC immediately and seek emergency medical care if they experience these symptoms. Do not prescribe COMBOGESIC for patients with acetaminophen allergy [see Contraindications (4)].
Stop Combogesic at the first appearance of skin rash or any other sign of hypersensitivity.
Heading
5.9 Serious Skin Reactions
Source text (exact source wording)
Inform patients about the signs and symptoms of serious skin reactions and to discontinue the use of COMBOGESIC at the first appearance of skin rash or any other sign of hypersensitivity.
Avoid Combogesic in pregnant women at about 30 weeks gestation and later because of the risk of premature closure of the fetal ductus arteriosus.
Heading
5.11 Fetal Toxicity
Source text (exact source wording)
Avoid use of NSAID-containing products, including COMBOGESIC, in pregnant women at about 30 weeks gestation and later. NSAID-containing products, including COMBOGESIC, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
If you have signs of anemia, hemoglobin or hematocrit should be monitored. NSAIDs may increase the risk of bleeding.
Heading
5.12 Hematologic Toxicity
Source text (exact source wording)
If a patient treated with COMBOGESIC has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including the ibuprofen in COMBOGESIC, may increase the risk of bleeding events.
NSAIDs, including the ibuprofen in COMBOGESIC, may increase the risk of bleeding events.
Pregnancy and breastfeeding
NSAIDs such as the ibuprofen in Combogesic can harm the unborn baby's heart blood vessel and kidneys. The dose and time should be limited between about 20 and 30 weeks of pregnancy, and Combogesic should be avoided at about 30 weeks and later. Both ingredients are present in human milk, and the benefits of breastfeeding should be weighed against the mother's need for the medicine. Withdrawal should be considered in women who have difficulty conceiving.
Section
8.1 Pregnancy; 8.2 Lactation; 8.3 Females and Males of Reproductive Potential (excerpts)
Source text (exact source wording)
Use of NSAID-containing products, including COMBOGESIC, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of COMBOGESIC use between about 20 and 30 weeks of gestation and avoid COMBOGESIC use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data).
8.2 Lactation: The components of COMBOGESIC, ibuprofen and acetaminophen, are present in human milk. ... The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COMBOGESIC and any potential adverse effects on the breastfed infant from COMBOGESIC or from the underlying maternal condition.
8.3 Infertility: Consider withdrawal of NSAID containing products, including COMBOGESIC in women who have difficulties conceiving or who are undergoing investigation of infertility.
8.2 Lactation: The components of COMBOGESIC, ibuprofen and acetaminophen, are present in human milk. ... The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COMBOGESIC and any potential adverse effects on the breastfed infant from COMBOGESIC or from the underlying maternal condition.
8.3 Infertility: Consider withdrawal of NSAID containing products, including COMBOGESIC in women who have difficulties conceiving or who are undergoing investigation of infertility.
Side effects
Common
The most common side effects (2% or more of people taking Combogesic) are nausea, vomiting, headache, dizziness, somnolence, post-procedural hemorrhage and swelling of the face.
Threshold
incidence of 2% or more (label wording: 'incidence of ≥ 2% for patients receiving COMBOGESIC')
Section
6 ADVERSE REACTIONS
Source text (exact source wording)
The most common adverse reactions (incidence of ≥ 2% for patients receiving COMBOGESIC) are: nausea, vomiting, headache, dizziness, somnolence, post-procedural hemorrhage, and swelling of the face (Table 1).
Less common
In the clinical trial table, Combogesic reactions below 2% were constipation (1), dyspepsia (0.4) and pruritus (0.4). For comparison, nausea was 15 with Combogesic and 23 with placebo, and headache was 5 with Combogesic and 7 with placebo.
Section
6.1 Clinical Trials Experience, Table 1 (percentages of patients; below-threshold rows for COMBOGESIC: constipation 1, dyspepsia 0.4, pruritus 0.4)
Source text (exact source wording)
Table 1: Most commonly (≥2%) reported adverse reactions by organ system during double-blind treatment
COMBOGESIC Acetaminophen Ibuprofen Placebo
N=261 N=231 N=231 N=199
Total number of AEs 145 142 101 133
% of patients with ≥1 AE 30 38 29 37
Gastrointestinal disorders
Nausea 15 19 12 23
Vomiting 7 10 3 10
Constipation 1 2 1 1
Dyspepsia 0.4 1 2 1
Injury, poisoning and procedural complications
Post Procedural Hemorrhage 2 0.4 1 2
Nervous system disorders
Headache 5 6 4 7
Dizziness 3 4 4 5
Somnolence 2 1 0 1
Skin and subcutaneous tissue disorders
Swelling face 2 4 4 3
Pruritus 0.4 0.4 0.4 3
COMBOGESIC Acetaminophen Ibuprofen Placebo
N=261 N=231 N=231 N=199
Total number of AEs 145 142 101 133
% of patients with ≥1 AE 30 38 29 37
Gastrointestinal disorders
Nausea 15 19 12 23
Vomiting 7 10 3 10
Constipation 1 2 1 1
Dyspepsia 0.4 1 2 1
Injury, poisoning and procedural complications
Post Procedural Hemorrhage 2 0.4 1 2
Nervous system disorders
Headache 5 6 4 7
Dizziness 3 4 4 5
Somnolence 2 1 0 1
Skin and subcutaneous tissue disorders
Swelling face 2 4 4 3
Pruritus 0.4 0.4 0.4 3
Serious
After approval, reports include serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and fixed drug eruption. The label's warnings also describe liver failure, heart attack, stroke, serious stomach and intestine bleeding, kidney injury and severe allergic reactions.
Label section
6.2 Postmarketing Experience; plus Warnings 5.1 to 5.12
Medlineplus section
n/a
Label source text (exact source wording)
6.2 Postmarketing Experience: The following adverse reactions have been identified during postapproval use of acetaminophen and ibuprofen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).
Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).
Interactions
Drugs
Ibuprofen with anticoagulants such as warfarin raises the risk of serious bleeding. Monitor for bleeding when used with anticoagulants, antiplatelet agents such as aspirin, SSRIs or SNRIs.
Name
Anticoagulants, antiplatelets, SSRIs, SNRIs
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
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 reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12)].
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 reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12)].
Using Combogesic with analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Combogesic is not a substitute for low dose aspirin for heart protection.
Name
Aspirin
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
Concomitant use of COMBOGESIC and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.3)].
COMBOGESIC is not a substitute for low dose aspirin for cardiovascular protection.
COMBOGESIC is not a substitute for low dose aspirin for cardiovascular protection.
NSAIDs may weaken the blood pressure lowering effect of ACE inhibitors, ARBs and beta-blockers, including propranolol. Blood pressure should be monitored.
Name
ACE inhibitors, ARBs and beta-blockers
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
NSAIDs reduced the effect of loop diuretics such as furosemide and thiazide diuretics in some patients.
Name
Diuretics
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
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.
Ibuprofen with digoxin has been reported to increase digoxin levels, so digoxin levels should be monitored.
Name
Digoxin
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
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.
Intervention: During concomitant use of COMBOGESIC and digoxin, monitor serum digoxin levels.
NSAIDs have raised lithium levels, so monitor for signs of lithium toxicity.
Name
Lithium
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance.
Intervention: During concomitant use of COMBOGESIC and lithium, monitor patients for signs of lithium toxicity.
Intervention: During concomitant use of COMBOGESIC and lithium, monitor patients for signs of lithium toxicity.
NSAIDs with methotrexate may increase the risk of methotrexate toxicity.
Name
Methotrexate
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
NSAIDs with cyclosporine may increase the kidney toxicity of cyclosporine.
Name
Cyclosporine
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
Concomitant use of NSAIDS and cyclosporine may increase cyclosporine's nephrotoxicity.
Using ibuprofen with other NSAIDs or salicylates is not recommended.
Name
Other NSAIDs and salicylates
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
The concomitant use of ibuprofen with other NSAIDs or salicylates is not recommended.
NSAIDs with pemetrexed may increase the risk of bone marrow suppression, kidney and GI toxicity.
Name
Pemetrexed
Section
7 DRUG INTERACTIONS (Table 2)
Source text (exact source wording)
Concomitant use of NSAIDS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Food and alcohol
The risk of acute liver failure is higher in people who drink alcohol while taking acetaminophen.
Name
Alcohol
Section
5.1 Hepatotoxicity; 5.3
Source text (exact source wording)
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Name
Grapefruit / food
Other
Do not take Combogesic with other acetaminophen- or NSAID-containing products.
Name
Other acetaminophen-containing products
Section
2 DOSAGE AND ADMINISTRATION
Source text (exact source wording)
Do not co-administer COMBOGESIC with other acetaminophen- or NSAID-containing products [see Warnings and Precautions (5.1, 5.2, 5.3)].
Patient tips
Take only as directed, at the lowest dose for the shortest time. Check labels for acetaminophen or APAP and do not use more than one product that contains it. Stop and get help for a skin rash or signs of a severe allergic reaction.
Label
Section
5.1; 5.9
Medlineplus
Section
n/a
Alternatives
Class statement
Source text (exact source wording)
COMBOGESIC is a combination of acetaminophen and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and is indicated in adults for the short term management of mild to moderate acute pain (1).
Recommendation
none (not ranked)
Frequently asked questions
Question
What is Combogesic used for?
Answer
Combogesic is for adults for the short-term management of mild to moderate acute pain.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed COMBOGESIC label (AFT Pharmaceuticals)
Question
How many Combogesic tablets can I take?
Answer
The recommended dose is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day. Use the lowest effective dose for the shortest time.
Source section
2 DOSAGE AND ADMINISTRATION
Source
DailyMed COMBOGESIC label
Question
Can I take Combogesic with other pain relievers?
Answer
No. The label says not to co-administer it with other acetaminophen- or NSAID-containing products. Using ibuprofen with other NSAIDs or salicylates is not recommended.
Source section
2 DOSAGE AND ADMINISTRATION; 7 DRUG INTERACTIONS
Source
DailyMed COMBOGESIC label
Question
What are the most common side effects?
Answer
The most common side effects (2% or more) are nausea, vomiting, headache, dizziness, somnolence, post-procedural hemorrhage and swelling of the face.
Source section
6 ADVERSE REACTIONS
Source
DailyMed COMBOGESIC label
Question
Is Combogesic safe during pregnancy?
Answer
The dose and time should be limited between about 20 and 30 weeks of pregnancy, and Combogesic should be avoided at about 30 weeks and later because of the risk of premature closure of the fetal ductus arteriosus and kidney problems in the baby.
Source section
5.11 Fetal Toxicity; 8.1 Pregnancy
Source
DailyMed COMBOGESIC label
Question
Does Combogesic affect the liver?
Answer
Acetaminophen has been associated with acute liver failure, mostly at doses that exceed 4,000 milligrams per day and often involving more than one acetaminophen-containing product. Combogesic has not been studied in people with impaired liver function, and use in them is not recommended.
Source section
BOXED WARNING; 5.1 Hepatotoxicity
Source
DailyMed COMBOGESIC label
Question
Which medicines interact with Combogesic?
Answer
Anticoagulants such as warfarin, aspirin, SSRIs and SNRIs raise bleeding risk. ACE inhibitors, ARBs, beta-blockers and diuretics may be less effective. Digoxin, lithium, methotrexate, cyclosporine and pemetrexed also interact. Tell your doctor and pharmacist about everything you take.
Source section
7 DRUG INTERACTIONS
Source
DailyMed COMBOGESIC label
Question
Is this the same as over-the-counter Advil Dual Action or Motrin Dual Action?
Source section
DailyMed list titles (not label text)
Source
DailyMed list API titles
Sources
- DailyMed COMBOGESIC label (primary, brand-only)
Set id: f863558f-2a44-41f8-a6b7-271851d4c2ff · Label effective or revised date: Revised: 9/2026 (Highlights show 'Warnings and Precautions (5.9) 11/2024' as a recent major change) · Dailymed version date: DailyMed list API published_date Jul 17, 2026 · Fetched at: 2026-11-03 · Sections used: Boxed warning, 1 to 8.6 (first 50,000 characters) plus a short slice of 16 Storage - Alternate label 1 (not opened, revised date NOT READ)
Set id: b32651c4-7fa0-415b-91eb-854aa1c28f2a · Label effective or revised date: NOT READ · Dailymed version date: published Jan 16, 2025 (list API) - Alternate label 2 (repackager, not opened)
Set id: f3cee991-19ef-4a1c-bb14-cbc8b6f32776 · Label effective or revised date: NOT READ · Dailymed version date: published Aug 24, 2026 (list API) - DailyMed list API (titles only)
Fetched at: 2026-11-02 - MedlinePlus
- Drugs@FDA
- openFDA
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug