What is the most important information I should know about ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

You should take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA exactly as prescribed, at the lowest dose possible and for the shortest time needed.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA may help reduce the risk of stomach ulcers from aspirin use, but you could still have bleeding and stomach or intestine ulcers, or other serious stomach or intestine problems. Talk with your doctor.

Tell your doctor if you have unexpected bleeding, if you bleed more than usual, or if your bleeding lasts longer than is normal for you, such as increased bruising or more frequent nose bleeds.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA contains aspirin, a nonsteroidal anti-inflammatory drug (NSAID) and omeprazole, a proton pump inhibitor (PPI) medicine. Before taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, tell your doctor if you take:

• aspirin, or any prescription or over-the-counter medicines containing aspirin or other NSAIDs.
• clopidogrel bisulphate (PLAVIX®). You should not take clopidogrel bisulphate (PLAVIX®) if you take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA.
• ticagrelor (BRILINTA®).

Do not stop taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA without talking with your doctor. Stopping ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA suddenly could increase your risk of having a heart attack or stroke.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
• Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA can have other serious side effects. See "What are the possible side effects of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?"

What is ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA is a prescription medicine used:

• in people who have had heart problems or strokes caused by blood clots, to help reduce their risk of further heart problems or strokes, and
• who are at risk of developing stomach ulcers with aspirin.

The aspirin in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA is used:

• to help reduce the risk of strokes and death in people who have previously had certain types of "mini strokes" (transient ischemic attacks or TIAs) or strokes.
• to help reduce the risk of heart attack and death in people who have previously had a heart attack or a type of chest pain called unstable angina pectoris.
• to help reduce the risk of heart attack and sudden death in people with a type of ongoing chest pain called chronic stable angina pectoris.
• in people who have had surgery or a procedure to improve blood flow to their heart, such as coronary artery bypass grafting (CABG), or percutaneous transluminal coronary angioplasty (PTCA), and who already have another condition that is being treated with aspirin.

The omeprazole in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA is used:

• to help decrease the risk of developing stomach ulcers due to aspirin in people who are 55 years of age or older, or who have a history of stomach ulcers.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA should not be used to treat sudden signs and symptoms of a heart attack or stroke. ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA should only be used as directed by your doctor to help reduce the risk of further heart problems or strokes.

It is not known if ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA is safe and effective in children.

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA has not been shown to reduce the risk of bleeding in the stomach or intestines that is caused by aspirin.

You should not take an aspirin tablet and an omeprazole tablet together instead of taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, because they will not work the same way.

Do not take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA if you:

• are allergic to aspirin, omeprazole, any other PPI medicine, or any of the ingredients in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. See the end of this Medication Guide for a complete list of ingredients in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA.
• are allergic to any nonsteroidal anti-inflammatory drug (NSAID).
• have a medical condition with severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), sneezing, runny nose or itchy nose (rhinitis), and growths inside of your nose or sinuses (nasal polyps).
• are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Do not give ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA to a child who has a suspected viral infection, even if they do not have a fever. There is a risk of Reye's syndrome with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA because it contains aspirin.

Before taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, tell your doctor about all of your medical conditions, including if you:

See "What is the most important information I should know about ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?"

• have any bleeding problems.
• drink 3 or more drinks that contain alcohol every day.
• have kidney or liver problems.
• have been told that you have low magnesium levels in your blood.
• are of Asian descent and have been told that your body's ability to break down (metabolize) omeprazole is poor or if your genotype called CYP2C19 is not known.
• are pregnant or plan to become pregnant. Talk to your doctor if you are considering taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA during pregnancy. You should not take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA after 29 weeks of pregnancy.
• are breastfeeding or plan to breastfeed. The aspirin and omeprazole in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA can pass into your breast milk and may harm your baby. Breastfeeding is not recommended during treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. Talk to your doctor about the best way to feed your baby if you take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA.
• are a female who can become pregnant. ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA may be related to infertility in some women that is reversible when treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA is stopped.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your doctor first.

Especially tell your doctor if you take:

• clopidogrel bisulphate (PLAVIX®)
• ticagrelor (BRILINTA®)
• St. John's Wort (Hypericum perforatum)
• rifampin (Rimactane, RIFATER®, RIFAMATE® RIFADIN®)
• methotrexate (Otrexup, Rasuvo, Trexall, XATMEP)
• digoxin (LANOXIN)
• a water pill (diuretic)

How should I take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

• Take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA exactly as prescribed by your doctor.
• Take 1 ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA tablet 1 time each day.
• Take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA at least 1 hour before a meal.
• Swallow ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA tablets whole with liquid. Do not split, chew, crush, or dissolve ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA.
• If you miss a dose of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to.
• If you take too much ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

What should I avoid while taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

Avoid heavy alcohol use during treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. People who drink three or more drinks that contain alcohol every day have a higher risk of bleeding during treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA because it contains aspirin.

What are the possible side effects of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA can cause serious side effects, including:

See "What is the most important information I should know about ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?"

• Stomach and intestine problems. Stop taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA and call your doctor right away if you have symptoms of stomach and intestine problems, including black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds, or severe nausea, vomiting, or stomach pain.
• Kidney failure. Long-lasting (chronic) kidney failure can happen with regular use of aspirin, a medicine in ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. This is more likely to happen in people who already have kidney problems before treatment with ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. Tell your doctor if you have symptoms of kidney failure, including changes in urination, swelling of the hands, ankles or feet, skin rash or itching, or your breath smells like ammonia.
• Liver problems. Long-term use of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA at certain doses may cause liver problems. Tell your doctor if you have symptoms of liver problems, including yellowing of your skin or your eyes, stomach-area (abdominal) pain and swelling, itchy skin, and dark (tea-colored) urine.
• Low vitamin B-12 levels. Low vitamin B-12 levels in your body can happen in people who have taken ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms or legs.
• Low magnesium levels. Low magnesium levels in your body can happen in people who have taken ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, and chest pain behind the breastbone, for example, with eating.

These are not all the possible side effects of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA?

• Store ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA at room temperature between 68°F to 77°F (20°C to 25°C).
• Store ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA in the original container.
• Keep the container of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA tightly closed to protect from moisture.
• The ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA container may contain a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the container. Do not throw away the desiccant packet.

Keep ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA and all medicines out of the reach of children.

General information about the safe and effective use of ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA for a condition for which it was not prescribed. Do not give ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA that is written for health professionals.