• One capsule twice daily (morning and evening) with or without food (2)
• In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning; resume BID dosing within one week (2)
• Do not chew capsule (2)
• Not interchangeable with the individual components of aspirin and dipyridamole tablets (2)
• Dispense in this unit-of-use container (16)

• Hypersensitivity to any product ingredients (4.1)
• Patients with known allergy to NSAIDs (4.2)
• Patients with the syndrome of asthma, rhinitis, and nasal polyps (4.2)

• AGGRENOX increases the risk of bleeding (5.1)
• Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3)
• Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4)

• The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea (6)

To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Co-administration with anticoagulants, antiplatelets, or NSAIDS can increase risk of bleeding (7.1)
• Decreased renal function can occur with co-administration with NSAIDS (7.1)

• Pregnancy Category D (8.1)