MOTRIN® Tablets for Pain and Symptom Relief

ABOUT THIS MEDICATION: 
MOTRIN® should not be used if you:

•  are taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication, including any other ibuprofen product.
• are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see non-medicinal ingredients). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
• have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
• have been diagnosed with severe high blood pressure or have severe coronary artery disease.
• are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
• have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis).
• have liver or kidney disease.
• have systemic lupus erythematosus.
• are in your third trimester of pregnancy.
• right before or after heart surgery

WARNINGS AND PRECAUTIONS:

Stomach bleeding warning: This product may cause stomach bleeding. Symptoms may include: 

• feeling faint
• vomiting blood
• bloody or black stools

The chance of stomach bleeding is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs, have 3 or more alcoholic drinks every day while using this product. 

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to ASA. Stop use and get medical help right away if you have: severe itching, hives, swelling of eyes and mouth, skin blisters/rash, difficulty breathing, shock.

Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.

Keep this medication out of the reach of children.

BEFORE you use MOTRIN® talk to your doctor or pharmacist if you:

• have stomach ulcers, high blood pressure, asthma, heart failure or thyroid disease, kidney or liver disease, glaucoma, diabetes, alcoholism, a history of stomach bleeding, systemic lupus erythematosus, or any other serious disease or condition.
• are taking an anticoagulant (blood thinning medication), oral corticosteroid or any other drug.
• are trying to conceive, in your first or second trimester of pregnancy or nursing.
• are over 65 years of age.
• are taking low-dose ASA.
• suffer from asthma or have nasal polyps (a swelling inside the nose).
• are dehydrated (severe fluid loss).
• have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.).
• have a heart disease.
• have any unusual urinary symptoms (e.g. bladder problems).
• are on a special diet (e.g. low-sodium).
• suffer from hyperkalemia (high levels of potassium in your blood).

They may recommend an alternative analgesic such as acetaminophen.
Long-term continuous use may increase the risk of heart attack or stroke.
Children’s MOTRIN® formulations are available to treat children under 12 years of age.

INTERACTIONS WITH THIS MEDICATION:
Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.

Drugs that may interact with MOTRIN® include: acetylsalicylic acid (ASA) or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), oral steroids (glucocorticoids), lithium, diabetes medications (hypoglycemics), methotrexate, phenytoin, acetaminophen and digoxin.

Do not use this product if you are taking daily low dose ASA (81-325 mg) without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:
If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhea, heartburn, bloating or constipation, fluid retention, skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, vomiting blood, tarry stools, jaundice (yellowing of the eyes or skin due to liver problems).

If you experience dizziness, blurred vision, or hearing problems while taking MOTRIN®, please use caution when carrying out activities requiring alertness.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking MOTRIN®, contact your doctor or pharmacist.

HOW TO STORE IT
Store at 15 to 30°C.