Soothe Regular Strength 262 mg/15 mL oral suspension

Generic name:
Bismuth subsalicylate - oral

Pronunciation
(BIZ-muth SUB-sa-LIS-i-late)

Brand name(s)
Pepto-Bismol , Pink Bismuth

This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms.

This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Take this medication by mouth, usually as needed, as directed by the product package or as directed by your doctor. The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age. There are many brands and forms of bismuth subsalicylate available. Read the dosing instructions carefully for each product because the dosing directions may be different between products.

If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, shake the bottle well before each dose. Measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

This medication may react with other medications (such as tetracycline antibiotics, chloroquine), preventing them from being fully absorbed by your body. Talk with your doctor or pharmacist about how to schedule your medications to prevent this problem.

If your doctor has directed you to use this medication daily, use it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition lasts or gets worse. If you are taking this medication for diarrhea, tell your doctor if your diarrhea lasts more than 2 days.

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 your doctor 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.

Vomiting/diarrhea that doesn't stop may result in 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 right away if you have any serious side effects, including:

• ringing ears
• hearing loss

This drug may rarely 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 right away:

• stomach/abdominal pain that doesn't go away
• vomit that looks like coffee grounds
• black/tarry/bloody stools

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems (such as hemophilia)
• bloody/black/tarry stools
• 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 younger than 18 years 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.

Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy. 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 breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• valproic acid
• carbonic anhydrase inhibitors (such as acetazolamide)
• corticosteroids (such as prednisone)
• dichlorphenamide
• methotrexate

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that are similar to this drug and, if taken together, may increase your risk for side effects. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medication may interfere with certain medical/lab tests (such as x-rays of the intestines using contrast dye), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: ringing ears, hearing loss.

If your doctor prescribes this medication for you, do not share it with others.

If you are taking this medication for diarrhea, drink plenty of water to decrease the risk of dehydration. Consult your doctor or pharmacist for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.