Trilisate is a non-steroidal anti-inflammatory drug (NSAID) that works by reducing substances in the body that cause pain, fever, and inflammation.

Trilisate is used to treat mild-to-moderate pain, fever, inflammatory conditions, and pain, swelling, or stiffness associated with arthritis. Trilisate is also used to reduce fever in adults.

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

Do not take more of Trilisate than recommended on the label. An overdose of choline magnesium trisalicylate can be fatal.

You should not use this medicine if you are allergic to salicylates (such as aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Trilisate may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Trilisate is usually given 2 to 3 times per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

Take with food if Trilisate upsets your stomach.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Trilisate doses are based on weight in children, and any changes may affect your child's dose.

While using Trilisate, you may need frequent blood tests.

If you need surgery, tell the surgeon ahead of time that you are using Trilisate. You may need to stop using the medicine for a short time.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Trilisate.

It may take up to 3 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

You should not use Trilisate if you are allergic to it, or if you have ever had:

• a severe allergic reaction after taking aspirin or other salicylates, such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Trilisate may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

To make sure Trilisate is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• a stomach ulcer or stomach bleeding;

• asthma;

• diabetes; or

• if you drink more than 3 alcoholic beverages per day.

Taking Trilisate 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.

Choline magnesium trisalicylate can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Trilisate can be fatal.

Overdose symptoms may include vomiting, diarrhea, sweating more than usual, ringing in your ears, confusion, trouble breathing, and severe dizziness or drowsiness.

Drinking alcohol may increase your risk of stomach bleeding.

Smoking can also increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain salicylates or NSAIDs. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, naproxen, or a salicylate.

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

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

• trouble breathing;

• ringing in your ears, hearing loss;

• behavior changes with nausea and vomiting in a child using this medicine;

• worsening fever or pain; or

• signs of stomach bleeding--feeling light-headed, ongoing stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of Trilisate may include:

• nausea, vomiting, stomach pain;

• heartburn, indigestion; or

• diarrhea, constipation.

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.

Warnings

Do not take more of Trilisate than recommended on the label. An overdose of choline magnesium trisalicylate can be fatal.

You should not use this medicine if you are allergic to salicylates (such as aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Trilisate may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Before taking this medicine

You should not use Trilisate if you are allergic to it, or if you have ever had:

• a severe allergic reaction after taking aspirin or other salicylates, such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

Do not give this medicine to a child or teenager with a fever, flu symptoms, or chicken pox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Trilisate may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

To make sure Trilisate is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• a stomach ulcer or stomach bleeding;

• asthma;

• diabetes; or

• if you drink more than 3 alcoholic beverages per day.

Taking Trilisate 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.

Choline magnesium trisalicylate can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Trilisate?

Trilisate is usually given 2 to 3 times per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

Take with food if Trilisate upsets your stomach.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Trilisate doses are based on weight in children, and any changes may affect your child's dose.

While using Trilisate, you may need frequent blood tests.

If you need surgery, tell the surgeon ahead of time that you are using Trilisate. You may need to stop using the medicine for a short time.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Trilisate.

It may take up to 3 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Trilisate can be fatal.

Overdose symptoms may include vomiting, diarrhea, sweating more than usual, ringing in your ears, confusion, trouble breathing, and severe dizziness or drowsiness.

What should I avoid while taking choline magnesium trisalicylate?

Drinking alcohol may increase your risk of stomach bleeding.

Smoking can also increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain salicylates or NSAIDs. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, naproxen, or a salicylate.

What other drugs will affect Trilisate?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• methotrexate;

• glaucoma medicine;

• gout medicine;

• insulin or oral diabetes medicine;

• a steroid medicine;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• seizure medicine--phenytoin, valproic acid.

This list is not complete. Other drugs may interact with choline magnesium trisalicylate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• methotrexate;

• glaucoma medicine;

• gout medicine;

• insulin or oral diabetes medicine;

• a steroid medicine;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• seizure medicine--phenytoin, valproic acid.

This list is not complete. Other drugs may interact with choline magnesium trisalicylate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.