Dosing & Uses
Dosage Forms & Strengths
tablet, chewable
- 262mg
- 525mg
caplet
- 262mg
oral suspension
- 262mg/15mL
- 525mg/15mL
- 525 mg/30 mL
- 1050 mg/30 mL
Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea
2 tablets (262 mg/tab) or 30 mL (regular strength) PO q½-1hr PRN; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses
Traveler's Diarrhea
Prophylaxis
2 tablets (262 mg/tab) q6hr for up to 3 weeks
Helicobacter Pylori
525 mg (2 regular-strength tablets or 1 extra-strength tablet) + 250 mg metronidazole + 500 mg tetracycline PO q6hr for 14 days, plus an H2 antagonist (Helidac Therapy pack)
Dosing Modifications
Renal impairment: Overdose may cause nephrotoxicity
Administration
Drink plenty of clear fluids to prevent dehydration caused by diarrhea
Do not use for >2 days
Helidac Therapy pack: Bismuth subsalicylate tablets should be chewed and swallowed; if a dose is missed, double doses should not be taken
Dosage Forms & Strengths
tablet, chewable
- 262mg
oral suspension
- 262mg/15mL
- 525mg/15mL
- 525 mg/30 mL
- 1050 mg/30 mL
Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea
<3 years: Safety and efficacy not established
3-6 years: 1/3 tablet or 5 mL (regular strength) or 2.5 mL (extra strength) PO q½-1hr PRN
6-9 years: 2/3 tablet or 10 mL (regular strength) or 5 mL (extra strength) PO q½-1hr PRN
9-12 years: 1 tablet or 15 mL (regular strength) or 7.5 mL (extra strength) PO q½-1hr PRN
>12 years: 2 tablets or 30 mL (regular strength) or 15 mL (extra strength) PO q½-1hr PRN; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses
Chronic Infantile Diarrhea
<2 years: 2.5 mL (regular strength) q4hr
2-4 years: 5 mL (regular strength) q4hr
4-6 years: 10 mL (regular strength) q4hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- dichlorphenamide
dichlorphenamide increases levels of bismuth subsalicylate by unknown mechanism. Contraindicated. Coadministration of dichlorphenamide with high-dose aspirin may increase salicylate levels. Anorexia, tachypnea, lethargy, and coma reported.
Serious - Use Alternative (7)
- demeclocycline
bismuth subsalicylate decreases levels of demeclocycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- doxycycline
bismuth subsalicylate decreases levels of doxycycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- eluxadoline
bismuth subsalicylate, eluxadoline. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration with other drugs that cause constipation. Increases risk for constipation related serious adverse reactions. .
- minocycline
bismuth subsalicylate decreases levels of minocycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- oxytetracycline
bismuth subsalicylate decreases levels of oxytetracycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- tetracycline
bismuth subsalicylate decreases levels of tetracycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- warfarin
bismuth subsalicylate increases effects of warfarin by anticoagulation. Avoid or Use Alternate Drug.
Monitor Closely (21)
- acebutolol
bismuth subsalicylate, acebutolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- atenolol
bismuth subsalicylate, atenolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- benazepril
bismuth subsalicylate decreases effects of benazepril by pharmacodynamic antagonism. Use Caution/Monitor. Salicylates may also increase nephrotoxic effects of ACE inhibitors.
- betaxolol
bismuth subsalicylate, betaxolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- bisoprolol
bismuth subsalicylate, bisoprolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- carvedilol
bismuth subsalicylate, carvedilol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- celiprolol
bismuth subsalicylate, celiprolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- esmolol
bismuth subsalicylate, esmolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- labetalol
bismuth subsalicylate, labetalol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- metoclopramide intranasal
bismuth subsalicylate will decrease the level or effect of metoclopramide intranasal by Other (see comment). Use Caution/Monitor. Coadministration of metoclopramide intranasal with drugs that impair GI motility may decrease systemic absorption of metoclopramide. Monitor for reduced therapeutic effect.
- metoprolol
bismuth subsalicylate, metoprolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- nadolol
bismuth subsalicylate, nadolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- nebivolol
bismuth subsalicylate, nebivolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- omadacycline
bismuth subsalicylate will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- penbutolol
bismuth subsalicylate, penbutolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- pindolol
bismuth subsalicylate, pindolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- propranolol
bismuth subsalicylate, propranolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- sarecycline
bismuth subsalicylate will decrease the level or effect of sarecycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.
- sotalol
bismuth subsalicylate, sotalol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- timolol
bismuth subsalicylate, timolol. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Blockage of renal prostaglandin synthesis; may cause severe hypertension.
- tobramycin inhaled
tobramycin inhaled and bismuth subsalicylate both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
Minor (5)
- aspirin
bismuth subsalicylate increases effects of aspirin by pharmacodynamic synergism. Minor/Significance Unknown.
- aspirin rectal
bismuth subsalicylate increases effects of aspirin rectal by pharmacodynamic synergism. Minor/Significance Unknown.
- aspirin/citric acid/sodium bicarbonate
bismuth subsalicylate increases effects of aspirin/citric acid/sodium bicarbonate by pharmacodynamic synergism. Minor/Significance Unknown.
- esomeprazole
esomeprazole increases levels of bismuth subsalicylate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- omeprazole
omeprazole increases levels of bismuth subsalicylate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
Adverse Effects
>10%
Nausea (12%)
1-10%
Diarrhea (7%)
Abdominal pain (7%)
Melena (3%)
Upper respiratory tract infection (2%)
Constipation (2%)
Anorexia (2%)
Vomiting (2%)
Asthenia (2%)
Discolored tongue (2%)
Headache (2%)
Dyspepsia (2%)
Dizziness (2%)
Stool abnormality (1%)
Duodenal ulcer (1%)
Sinusitis (1%)
Taste perversion (1%)
Flatulence (1%)
GI hemorrhage (1%)
Pain (1%)
Insomnia (1%)
Anal discomfort (1%)
Paresthesia (1%)
Frequency Not Defined
Anxiety
Confusion
Depression
Tinnitus
Weakness
Gray-black stool
Impaction
Muscle spasm
Neurotoxicity (rare)
Warnings
Contraindications
Hypersensitivity to bismuth, aspirin, other salicylates
Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or GI bleeding with black or bloody stool, hemophilia
In pediatric patients, chicken pox or influenza (risk of Reye syndrome)
Cautions
Bismuth subcitrate potassium may cause temporary and harmless darkening of tongue and/or black stools, generally reversible within several days after treatment stopped; stool darkening should not be confused with melena
Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of gastrointestinal tract
Cases of neurotoxicity associated with excessive doses of various bismuth-containing products reported; effects have been reversible with discontinuation of bismuth therapy
Not to be administered to children or teenagers recovering from flu-like symptoms or chickenpox; increased incidence of Reye syndrome, associated with salicylate products
Pregnancy & Lactation
Pregnancy category: C; D in 3rd trimester
Lactation: Salicylates enter breast milk; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antimicrobial anti-inflammatory action (bismuth); antisecretory effect (salicylate)
Absorption
Bioavailability: Bismuth, <1%; salicylate, 80%
Peak plasma time: Bismuth, 1.8-5 hr
Onset: 4 hr
Distribution
Protein bound: Bismuth, 90%; salicylate, >90%
Vd: Bismuth, 170 mL/kg
Metabolism
Stomach: Bismuth subsalicylate is hydrolyzed in stomach to form slightly soluble bismuth oxychloride (BiOCl) and salicylic acid
Small intestine: Unchanged bismuth subsalicylate passes into duodenum and reacts with other anions (eg, bicarbonate and phosphate) to form bismuth subcarbonate and bismuth phosphate salts
Colon: BiOCl, bismuth subcarbonate, bismuth phosphate, and undissociated bismuth subsalicylate react with hydrogen sulfide (produced by colonic anaerobes) to form black bismuth sulfide, which is responsible for harmless darkening of stool and/or tongue
Liver: Salicylate is extensively metabolized in liver
Metabolites: Salicylate (active); BiOCl, bismuth subcarbonate, and bismuth phosphate (activity unknown)
Elimination
Half-life: Bismuth, 21-72 days; salicylate, 2.5 hr
Excretion: Bismuth, feces (99%) and urine (0.003%); salicylate, urine (95%)
Clearance: Bismuth, 50 mL/min
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Stomach Relief oral - | 262 mg/15 mL suspension |  | |
| Stomach Relief oral - | 262 mg chewable tablet |  | |
| Stomach Relief oral - | 262 mg chewable tablet |  | |
| Stomach Relief oral - | 525 mg/15 mL suspension |  | |
| Bismatrol oral - | 262 mg chewable tablet | | |
| Diotame oral - | 262 mg chewable tablet |  | |
| Soothe Regular Strength oral - | 262 mg/15 mL suspension |  | |
| Soothe Regular Strength oral - | 262 mg/15 mL suspension |  | |
| Soothe Regular Strength oral - | 262 mg/15 mL suspension |  | |
| Soothe (bismuth subsalicylate) oral - | 262 mg tablet |  | |
| Bismuth oral - | 262 mg chewable tablet | | |
| Bismuth oral - | 262 mg tablet |  | |
| Stomach Relief Max Strength oral - | 525 mg/15 mL suspension |  | |
| Stomach Relief Max Strength oral - | 525 mg/15 mL suspension |  | |
| Pepto-Bismol oral - | 262 mg chewable tablet |  | |
| Pepto-Bismol oral - | 262 mg tablet |  | |
| Pepto-Bismol oral - | 262 mg/15 mL suspension |  | |
| Pepto-Bismol oral - | 262 mg/15 mL suspension |  | |
| Pepto-Bismol oral - | 262 mg/15 mL suspension |  | |
| Pepto-Bismol oral - | 262 mg chewable tablet |  | |
| Pepto-Bismol oral - | 262 mg/15 mL suspension |  | |
| Pepto-Bismol Max St oral - | 525 mg/15 mL suspension |  | |
| Pepto-Bismol Max St oral - | 525 mg/15 mL suspension |  | |
| Pepto-Bismol Max St oral - | 525 mg/15 mL suspension |  | |
| Pepto-Bismol Max St oral - | 525 mg/15 mL suspension |  | |
| Kaopectate (bismuth subsalicylate) oral - | 262 mg tablet |  | |
| Kaopectate (bismuth subsalicylate) oral - | 262 mg/15 mL suspension |  | |
| Stomach Relief Original oral - | 262 mg/15 mL suspension |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
bismuth subsalicylate oral
BISMUTH SUBSALICYLATE - ORAL
(BIZ-muth SUB-sa-LIS-i-late)
COMMON BRAND NAME(S): Pepto-Bismol, Pink Bismuth
USES: 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.
HOW TO USE: 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: 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/lightheadednessTell 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.
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.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 breast-feeding.
DRUG INTERACTIONS: 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. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day). Consult your doctor or pharmacist for more details.This medication may interfere with certain radiology exams (x-rays of the intestines using contrast dye), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing ears, hearing loss.
NOTES: 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.
MISSED DOSE: 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.
STORAGE: 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.
Information last revised May 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: 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.
