Kaolin Pectin Suspension

GENERIC NAME: BISMUTH SUBSALICYLATE (BIS-muth sub-sa-LIS-a-late)

COMMON USES: This medicine is an antidiarrheal agent used to treat diarrhea, stomach cramps, indigestion, and nausea. This medicine may also be used in combination with other medicines to treat ulcers or other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Use this medicine exactly as directed on the package, unless instructed differently by your doctor. SHAKE WELL before taking a dose. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose. This medicine may be taken with or without food. DO NOT TAKE tetracyclines (eg, doxycycline) within 2 hours before or after taking this medicine. DRINKING EXTRA FLUIDS while you are taking this medicine is recommended. Check with your doctor for instructions. STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION (eg, severe rash, hives, difficulty breathing, dizziness) to a salicylate (eg, aspirin) or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib). IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than 48 hours without checking with your doctor. If your symptoms do not improve within 48 hours, or if they become worse or you develop a fever, check with your doctor. THIS MEDICINE MAY COLOR THE TONGUE OR FECES gray or black. DO NOT GIVE THIS MEDICINE TO A CHILD OR TEENAGER who has chickenpox, the flu, or another viral infection. Use of this medicine for treating the symptoms of a viral infection may cause a serious illness called Reye's syndrome. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any medicine that contains aspirin. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include: temporary and harmless darkening of the tongue or stool. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: black, tarry stools; bloody or dark urine; fever; hearing loss; nausea; ringing in the ears; severe constipation; unusual bruising or bleeding; vomiting that may or may not look like coffee grounds. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: SOME MEDICINES MAY INTERACT with this medicine. DO NOT TAKE THIS MEDICINE if you are taking another salicylate medicine (eg, aspirin). TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: diabetes medicine (eg, insulin, glipizide), methotrexate, valproic acid; anticoagulants (eg, warfarin), clopidogrel, salicylates (eg, aspirin), NSAIDs (eg, ibuprofen, naproxen), angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), or sulfinpyrazone. This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including diabetes, gout, arthritis, fever, mucus in the stool, inflammation of the stomach, Kawasaki syndrome, kidney problems, chickenpox, the flu, joint problems (in children), dehydration; a history of stroke, stomach ulcers, a certain type of bulging blood vessel (aneurysm) in the brain; allergies; pregnancy; or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have bleeding problems (eg, hemophilia), an active bleeding ulcer, black or bloody stools, or von Willebrand disease. USE OF THIS MEDICINE IS NOT RECOMMENDED if the patient is a child with a viral infection (eg, chickenpox, flu symptoms). Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include coma; confusion; dehydration; dizziness; new or worsening nausea; ringing in the ears; seizures; unusual bruising or bleeding; vomiting.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.