Durlaza is a salicylate (sa-LIS-il-ate) that is used to treat pain, and reduce fever or inflammation.

Durlaza is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). This medicine should be used for these conditions only under the supervision of a doctor.

Durlaza may also be used for purposes not listed in this medication guide.

Durlaza can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Use exactly as directed on the label, or as prescribed by your doctor.

Always follow directions on the medicine label about giving Durlaza to a child.

Take with food if Durlaza upsets your stomach.

You must chew the chewable tablet before you swallow it.

Do not crush, chew, break, or open an enteric-coated or delayed/extended-release pill. Swallow it whole.

Tell your doctor if you have a planned surgery.

Store at room temperature away from moisture and heat.

Do not use Durlaza if you smell a strong vinegar odor in the this medicine bottle. The medicine may no longer be effective.

Using Durlaza in a child or teenager with flu symptoms or chickenpox can cause a serious or fatal condition called Reye's syndrome.

You should not use Durlaza if you are allergic to it, or if you have:

• a recent history of stomach or intestinal bleeding;

• a bleeding disorder such as hemophilia; or

• if you have ever had an asthma attack or severe allergic reaction after taking Durlaza or an NSAID (non-steroidal anti-inflammatory drug).

Tell your doctor if you have ever had:

• asthma or seasonal allergies;

• stomach ulcers;

• liver disease;

• kidney disease;

• a bleeding or blood clotting disorder;

• gout; or

• heart disease, high blood pressure, or congestive heart failure.

Taking Durlaza during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Durlaza.

Durlaza is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause stomach pain, vomiting, diarrhea, vision or hearing problems, fast or slow breathing, or confusion.

Avoid alcohol. Heavy drinking can increase your risk of stomach bleeding.

Avoid taking ibuprofen if you take Durlaza to prevent stroke or heart attack. Ibuprofen can make this medicine less effective in protecting your heart and blood vessels. Ask your doctor how far apart your doses should be.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Durlaza (such as magnesium salicylate, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Durlaza may cause serious side effects. Stop using Durlaza and call your doctor at once if you have:

• ringing in your ears, confusion, hallucinations, rapid breathing, seizure (convulsions);

• severe nausea, vomiting, or stomach pain;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• fever lasting longer than 3 days; or

• swelling, or pain lasting longer than 10 days.

Common side effects of Durlaza may include:

• upset stomach, heartburn;

• drowsiness; or

• mild headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Durlaza if you take an antidepressant. Taking certain antidepressants with this medicine may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using Durlaza with any other medications, especially:

• a blood thinner (warfarin, Coumadin, Jantoven), or other medication used to prevent blood clots; or

• other salicylates such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete. Other drugs may affect Durlaza, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.