When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to aspirin or other NSAIDs, or if you have a history of asthma with nasal polyps and rhinitis.

How to Use This Medicine:
Delayed Release Capsule, Long Acting Capsule, Gum, Tablet, Chewable Tablet, Fizzy Tablet, Coated Tablet, Long Acting Tablet, 24 Hour Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Capsule, tablet, or coated tablet: Swallow whole. Do not crush, break, or chew it.
• Chewable tablet: You may chew it completely or swallow it whole.
• Gum: Chew completely to make sure you get as much medicine as possible. Drink a full glass (8 ounces) of water after chewing the gum.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it. Take the capsule with a full glass of water at the same time each day.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Missed dose: If you miss a dose of Durlaza™, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how aspirin works. Tell your doctor if you are using any of the following:
  
  • Dipyridamole, methotrexate, probenecid, sulfinpyrazone, ticlopidine
  • Blood thinner (including clopidogrel, prasugrel, ticagrelor, warfarin)
  • Blood pressure medicine
  • Medicine to treat seizures (including phenytoin, valproic acid)
  • NSAID pain or arthritis medicine (including celecoxib, diclofenac, ibuprofen, naproxen)
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• Do not take Durlaza™ 2 hours before or 1 hour after you drink alcohol or take medicines that contain alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, high blood pressure, heart disease, or a history of stomach bleeding or ulcers.
• This medicine may increase your risk for bleeding, including stomach ulcers.
• Do not give aspirin to a child or teenager who has chickenpox or flu symptoms, unless the doctor says it is okay. Aspirin can cause a life-threatening reaction called Reye syndrome.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black stools, bloody vomit or vomit that looks like coffee grounds
• Chest tightness, wheezing
• Ringing in the ears
• Severe stomach pain
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088