Certain prescription omega-3 polyunsaturated fatty acids are used in adults, together with diet to help lower triglyceride levels in the blood.

Omega-3 polyunsaturated fatty acids may also be used in combination with other vitamins in adults and children as a dietary supplement.

Omega-3 polyunsaturated fatty acids may also be used for purposes not listed in this medication guide.

Use only as directed and follow all directions on the label and package. Tell each of your healthcare providers if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not use more of this product than is recommended on the label.

The recommended daily dose of omega-3 polyunsaturated fatty acids changes with age. Follow your healthcare provider's instructions. You may also consult the Office of Dietary Supplements of the NIH, or the USDA Nutrient Database of recommended daily allowances for more information.

Over the counter (OTC) products should not be used to replace medication prescribed for you by your doctor. Ask your doctor, pharmacist, or other healthcare provider if it is safe to use this product.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You must chew the chewable tablet before you swallow it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Your treatment may also include diet, exercise, weight control, and blood tests.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture, heat, and light. Do not freeze.

Usual Adult Dose for Hypertriglyceridemia:

1 gram prescription only products:
4 grams orally daily; may be given as a single dose or 2 divided doses.

Comments:
-Assess triglyceride levels carefully before starting therapy and identify other possible causes (e.g. diabetes, hypothyroidism, medications) and manage appropriately.
-Patients should be on a lipid lowering diet prior to using this medication, and continue the diet during use of this medication.
-Capsules should be swallowed whole; do not break, crush, chew or dissolve capsules.
-In clinical trials, the medication was administered with meals.

You should not use omega-3 polyunsaturated fatty acids if you are allergic to omega-3 polyunsaturated fatty acids, soy, fish or shellfish.

Ask your doctor or pharmacist before taking omega-3 polyunsaturated fatty acids if you have any health problems.

Tell your doctor if you have or have ever had:

• diabetes;

• bleeding problems, anemia (low red blood cells);

• a heart rhythm disorder;

• a pancreas disorder;

• underactive thyroid; or

• liver disease.

It is not known if omega-3 polyunsaturated fatty acids will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using omega-3 polyunsaturated fatty acids.

Do not give any herbal or health supplement to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Avoid using omega-3 polyunsaturated fatty acids together with other herbal/health supplements that can also affect blood-clotting. This includes angelica (dong quai), capsicum, clove, dandelion, danshen, evening primrose, garlic, ginger, ginkgo, horse chestnut, Panax ginseng, poplar, red clover, saw palmetto, turmeric, and willow.

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

Omega-3 polyunsaturated fatty acids may cause serious side effects. Call your doctor at once if you have:

• chest pain; or

• uneven heartbeats.

Common side effects of omega-3 polyunsaturated fatty acids may include:

• burping, changes in your sense of taste;

• loss of appetite;

• diarrhea, constipation, upset stomach;

• back pain; or

• dry mouth.

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.

Do not take omega-3 polyunsaturated fatty acids without medical advice if you are using any of the following medications:

• medicine used to prevent blood clots--alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or

• a blood thinner--warfarin, Coumadin, Jantoven, apixaban, rivaroxaban, dabigatran.

This list is not complete. Other drugs may affect omega-3 polyunsaturated fatty acids, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.