Duexis contains a combination of famotidine and ibuprofen. Famotidine is a histamine blocker. Famotidine works by decreasing the amount of acid the stomach produces.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Duexis is a combination drug. Ibuprofen treats the symptoms of arthritis. Famotidine helps reduce the risk of ulcers in the stomach or intestines that can be caused by long-term use of ibuprofen.

Taking famotidine (Pepcid) and ibuprofen (Advil, Motrin) together does not have the same effect as using Duexis.

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Duexis just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

Take Duexis exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

Duexis is usually taken 3 times each day.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of Duexis needed to get relief from your pain, swelling, or fever.

Do not crush, chew, or break a Duexis tablet. Swallow the tablet whole.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Osteoarthritis:

Famotidine 26.6 mg-Ibuprofen 800 mg (1 tablet) orally 3 times a day

Uses: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; and to decrease the risk of developing upper gastrointestinal ulcers, including gastric and/or duodenal ulcer in patients taking ibuprofen for those indications

Usual Adult Dose for Rheumatoid Arthritis:

Famotidine 26.6 mg-Ibuprofen 800 mg (1 tablet) orally 3 times a day

Uses: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; and to decrease the risk of developing upper gastrointestinal ulcers, including gastric and/or duodenal ulcer in patients taking ibuprofen for those indications

You should not use Duexis if you are allergic to famotidine or ibuprofen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ibuprofen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

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

• heart disease, high blood pressure;

• bleeding problems;

• liver or kidney disease;

• a stomach or intestinal disorder;

• a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, or lupus;

• asthma; or

• if you smoke or drink alcohol.

If you are pregnant, you should not take Duexis unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Duexis is not approved for use by anyone younger than 18 years old.

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.

Overdose symptoms may include weakness, drowsiness, nausea, or vomiting.

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

Avoid using other medications that contain ibuprofen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Get emergency medical help if you have signs of an allergic reaction to Duexis (sneezing, runny or stuffy nose; wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using ibuprofen and call your doctor at once if you have:

• changes in your vision;

• the first sign of any skin rash, no matter how mild;

• fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;

• severe headache, blurred vision, pounding in your neck or ears;

• little or no urination;

• swelling, rapid weight gain;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

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

Some side effects may be more likely in older adults and in people who have severe kidney disease.

Common Duexis side effects may include:

• nausea, stomach pain;

• diarrhea, constipation; or

• 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 taking Duexis if you take a blood thinner (warfarin, Coumadin), or an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with famotidine and ibuprofen. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.