Generic Name: BISMUTH SUBSALICYLATE - ORAL
Pronounced: (BIZ-muth SUB-sa-LIS-i-late)

Kaopectate Child(Bis ssalicyl) Oral Precautions

See also Uses section.

Before taking bismuth subsalicylate, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to aspirin, to salicylates (such as salsalate), or to NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• bleeding problems (such as hemophilia)
• bloody/black/tarry stools

If you have any of the following health problems, consult your doctor or pharmacist before using this medication

• gout

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug contains an aspirin-like product (salicylate). Children and teenagers should not take this product if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin or aspirin-like products increases the risk of Reye's syndrome, a rare but serious illness.

During the first 6 months of pregnancy, this medication should be used only when clearly needed because of the salicylate. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Kaopectate Child(Bis ssalicyl) Oral Side Effects

Side effects from this medication are rare. The most common side effects are darkening of the stools and/or tongue. These effects are harmless and will disappear when you stop the medication.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• ringing ears
• hearing loss

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, stop taking this medication and consult your doctor or pharmacist immediately:

• vomit that looks like coffee grounds
• black/tarry/bloody stools
• persistent stomach/abdominal pain

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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