Konsyl Fiber

• Konsyl Pharmaceuticals, Inc.

You should not use this medicine if you are allergic to polycarbophil or to mineral oil, sodium laurel sulfate, or povidone (such as Betadine).

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• irritable bowel syndrome;

• trouble swallowing;

• stomach pain with nausea or vomiting;

• a blockage in your intestines;

• a history of bleeding from your rectum;

• a sudden change in bowel habits that lasts 2 weeks or longer; or

• if you have been constipated for more than 1 week.

Ask your doctor before taking polycarbophil if you are pregnant or breast-feeding.

This medicine may contain phenylalanine. Talk to your doctor before taking polycarbophil if you have phenylketonuria (PKU).

Do not give this medicine to a young child without the advice of a doctor.

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

Call your doctor at once if you have:

• severe stomach cramps, rectal bleeding; or

• no bowel movement within 3 days after using polycarbophil.

Common side effects may include:

• mild stomach pain;

• bloating; or

• gas.

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.

• If you have an allergy to polycarbophil or any other part of Konsyl Fiber (polycarbophil tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have trouble swallowing.
• If you have any of these health problems: Bowel block, belly pain, upset stomach, rectal bleeding, throwing up, or change in bowel habits lasting >2 weeks.
• If you are taking any of these drugs: Demeclocycline, doxycycline, minocycline, or tetracycline.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Konsyl Fiber with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Be sure to take Konsyl Fiber with plenty of fluids. If you do not, this medicine may swell and block your throat. This could lead to choking. Talk with your doctor.
• This medicine prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Konsyl Fiber.
• Do not use this medicine for more than 1 week unless told to do so by your doctor.
• If you have rectal bleeding or you do not have a bowel movement after using Konsyl Fiber, talk with your doctor.
• Do not use other laxatives or stool softeners unless told to do so by the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Upset stomach or throwing up.
• Trouble swallowing.
• Trouble breathing.
• Belly pain.