Combogesic^®

325mg acetaminophen
97.5mg ibuprofen

Three 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).

• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

• Heart Failure and Edema: Avoid use of COMBOGESIC in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

• Renal Toxicity: Long-term administration of NSAIDs, including the ibuprofen component of COMBOGESIC, has resulted in renal papillary necrosis and other renal injury.

• Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

• Exacerbation of Asthma Related to Aspirin Sensitivity: COMBOGESIC is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

• Serious Skin Reactions: Discontinue COMBOGESIC at first appearance of skin rash or other signs of hypersensitivity.

• Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.

• Fetal Toxicity: Limit use of NSAID-containing products, including COMBOGESIC, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAID- containing products, including COMBOGESIC in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.

• Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

ADVERSE REACTIONS
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.

DRUG INTERACTIONS
A number of known or potential interactions between COMBOGESIC and other drugs/drug classes exist. This includes Aspirin, NSAIDS, Salicylates, Anticoagulants, Antiplatelet agents, SSRIs, SNRIs, ACE Inhibitors, Angiotensin Receptor Blockers, Beta-Blockers, Diuretics, Digoxin, Lithium, Methotrexate, Cyclosporine, and Pemetrexed.
Please refer to section 7, Drug Interactions, of the prescribing information for further information.

USE IN SPECIFIC POPULATIONS
• Infertility: NSAID-containing products, including COMBOGESIC, are associated with reversible infertility. Consider withdrawal of COMBOGESIC tablets in women who have difficulties conceiving.

• COMBOGESIC tablets are not recommended in patients with renal or hepatic impairment.

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.

To report SUSPECTED ADVERSE REACTIONS, contact AFT Pharmaceuticals US, Inc at 01-248-631-4810 or FDA at 1-800-FDA1088 or www.fda.gov/medwatch.