Combogesic® tablets contain a fixed-dose combination of 325 mg acetaminophen and 97.5 mg ibuprofen per tablet. These two active ingredients work via distinct yet complementary mechanisms to provide more effective acute pain relief than equivalent doses of each individual active alone.² 


Combogesic® offers a valuable option for the short-term management of mild to moderate acute pain in adults, with several key benefits. These include enhanced analgesic efficacy due to a synergistic action, simplified dosing through the combination of two agents in a single formulation, a well-established safety profile, and the potential to reduce reliance on opioids compared to monotherapy. 

Combogesic® tablets are approved for adults only (18 years and above). The dosing regimen is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day. 


Combogesic® tablets should be taken at the lowest effective dosage for the shortest duration, consistent with individual patient treatment goals, and should not be administered with other acetaminophen or NSAID-containing products.

Combogesic® tablets are contraindicated in: 

• Patients with known hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product. 
• Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. 
• The setting of coronary artery bypass graft (CABG) surgery 

Warning / Precaution is advised in those patients with:

• Hypertension 
• Heart Failure and Edema 
• Renal Toxicity 
• Anaphylactic Reactions 
• Exacerbation of Asthma Related to Aspirin Sensitivity 
• Serious Skin Reactions 
• Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) 
• Fetal Toxicity 
• Hematologic Toxicity 

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)

To find the full list of warning and contraindications please see full Prescribing Information including the boxed warning. 

Combogesic® is the only combination analgesic approved in the US containing acetaminophen and ibuprofen formulated in a 3.3:1 ratio, with multiple patents granted globally based on the synergistic effects demonstrated by this specific ratio. 

Clinical trials have confirmed that the patented 3.3:1 ratio used in Combogesic® delivers a synergistic combination that balances superior analgesic efficacy while minimizing the risk of adverse effects.

Studies have also highlighted the importance of maintaining this precise ratio between acetaminophen and ibuprofen, when the ratio falls below this threshold, the synergistic interaction between the two agents diminishes, and a higher dose of ibuprofen relative to acetaminophen is required to attain the desired analgesic effect. 

The separate administration of acetaminophen and ibuprofen does not replicate the superior efficacy observed with Combogesic® with its unique 3.3:1 ratio. This is due to changes in the drug ratio during separate dosing, where an increased proportion of ibuprofen relative to acetaminophen diminishes the synergistic effect. 


Furthermore, a 2018 study evaluating alternating dosing of the individual components did not demonstrate a statistically significant improvement in pain scores. Therefore, taking alternating doses of each individual active ingredient does not deliver the synergistic benefits uniquely associated with Combogesic®. These findings highlight that co-administration of both agents simultaneously is advisable to achieve enhanced analgesic efficacy.¹¹ 

Combogesic® is supported by a robust body of clinical data demonstrating its favorable safety profile. The postoperative safety profile of Combogesic® is comparable to that of acetaminophen and ibuprofen when used individually. By combining two active ingredients, Combogesic® enables the use of a lower dose of the NSAID component, thereby reducing the risk of adverse events typically associated with higher NSAID dosages or the use of more potent NSAIDs. 

Overall, Combogesic® is well tolerated and demonstrates a strong safety profile when administered as both single and multiple doses. 

Combogesic® tablets are intended for adults who need short-term relief of mild to moderate acute pain. They combine acetaminophen and ibuprofen, two active ingredients that work in different ways, providing more effective pain relief than either medicine alone.²

Healthcare professionals may recommend Combogesic® for:

• Common acute pain conditions.
• Situations where a non-opioid option is preferred to reduce risks of dependence or certain adverse effects.
• Patients who benefit from a multimodal approach, taking advantage of both medications together for consistent and reliable pain control.

The dosing allows patients to manage pain effectively while staying within dosing limits for acetaminophen and ibuprofen. Its patented formulation is designed for consistent, dependable relief, offering an advantage over taking the two medicines separately.