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If you have a medical question or to report an adverse event about PENNSAID®, call 800-778-7898. For all other inquiries, e-mail SpecialtyPharma.SalesOps@covidien.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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INDICATION
PENNSAID® is a nonsteroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s).

IMPORTANT RISK INFORMATION

WARNING: CARDIOVASCULAR (CV) AND GASTROINTESTINAL (GI) RISK

Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious blood clots in the heart, or cause a heart attack or stroke. These risks can cause death. The risk may increase the longer NSAIDs are used. Patients who have heart disease or are at risk for heart disease may be at greater risk
Do not use PENNSAID in patients who are in the hospital for heart bypass surgery grafts

NSAIDs cause an increased risk of serious stomach problems or problems in the intestines. Patients could bleed or develop a hole in their stomach or intestines. All of these problems can cause death. These problems can happen at any time with no warning when using NSAIDs. Older patients are at greater risk for these problems

Tell your doctor if you have:
• High blood pressure, heart failure, or had any heart surgeries
• A history of ulcers or bleeding in the stomach or intestines
• Kidney or liver problems

The most common side effects of PENNSAID occur where it is put on the skin such as dry skin (32%), red and firm skin rash, skin rash with blisters, and itching. Other common side effects include: upset stomach, stomach pain, gas, diarrhea, and nausea.

Serious reactions can occur even if you never used PENNSAID before. NSAIDs can cause bad skin reactions that can be fatal.

A rise in liver tests can occur with NSAID therapy. Stop PENNSAID if this occurs and does not go away or if it gets worse.

Using NSAIDs for a long time can hurt the kidneys. Use PENNSAID carefully in the elderly, those with damaged kidneys, bad hearts, bad livers, and those taking water pills or ACE inhibitors. Do not take other NSAIDS unless your physician says it is OK.

Do not use PENNSAID if you are pregnant or breast-feeding. Do not use PENNSAID on children.

Avoid exposing treated knee to the sun or tanning lamps. Wash and dry hands before and after use. Avoid contact of PENNSAID with the eyes, the mouth and the nose. Do not apply to open wounds. Do not apply heat or binding items to the treated knee.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more important risk information about PENNSAID, please read the PENNSAID Medication Guide and Full Prescribing Information and discuss any questions you have with your doctor.

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG.
PENNSAID is a registered trademark of Nuvo Research Inc. Other brands are trademarks of their respective owners. © 2011 Covidien