Combogesic

Combogesic is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN AND IBUPROFEN. It is labelled by Preferred Pharmaceuticals Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 68788-4181, application NDA209471, label effective 20260820. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN AND IBUPROFEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN AND IBUPROFEN are most often described in connection with: indicated adults, management mild, moderate acute, usage combogesic, combination acetaminophen, ibuprofen non-steroidal, anti-inflammatory drug, short term. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE COMBOGESIC is indicated in adults for the short-term management of mild to moderate acute pain. 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 ).

2 DOSAGE AND ADMINISTRATION • 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. • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2 ). • Do not administer with other acetaminophen-containing products ( 2 ). Three tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day ( 2 ).

4 CONTRAINDICATIONS 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) ] . COMBOGESIC is contraindicated in: • patients with known hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product ( 4 ). • 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 ( 4 ). • the setting of coronary artery bypass graft (CABG) surgery ( 4 ).

6 ADVERSE REACTIONS The following clinically significant adverse reactions to ibuprofen or acetaminophen are described elsewhere in other sections of the labelling. • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.2) ] • Gastrointestinal Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Heart Failure and Edema [see Warnings and Precautions (5.5) ] • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] • Anaphylaxis and Other Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] • Serious Skin Reactions [see Warnings and Precautions (5.9) ] • Hematologic Toxicity [see Warnings and Precautions (5.12) ] 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). The most common adverse reactions (greater than or equal to 2%) are nausea, vomiting, headache, dizziness, somnolence, post-procedural hemorrhage, and swelling of the face ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AFT Pharmaceuticals US, Inc at 01-248-631-4810 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to the rates reported from clinical trials of another drug and may not reflect the rates observed in practice. The clinical trials of COMBOGESIC have been conducted in patients with postoperative pain following dental and arthroscopic procedures, who received double-blind treatment every 6 hours for 24 or 48 hours. Most commonly (≥2%) reported adverse reactions by organ system during double-blind treatment are listed in the table below. Adverse reactions are closely related to the extent (the level and length) of exposure. The incidences of overall and individual adverse reactions reported during the double-blind treatment period did not suggest an increase of risks associated with short-term (up to one or two days) use of the combination drug, COMBOGESIC in comparison to each individual component, acetaminophen or ibuprofen, and to placebo. 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 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).

FDA lists 3 drug label records with ACETAMINOPHEN AND IBUPROFEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Combogesic used for?
1 INDICATIONS AND USAGE COMBOGESIC is indicated in adults for the short-term management of mild to moderate acute pain. 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 ).

Who makes Combogesic?
Preferred Pharmaceuticals Inc. is the labeler of record for Combogesic. 3 FDA label records share the active ingredient ACETAMINOPHEN AND IBUPROFEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Combogesic come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Combogesic prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN AND IBUPROFEN?
Yes. 3 FDA drug label records list ACETAMINOPHEN AND IBUPROFEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Combogesic been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.