Bismuth subsalicylate

Bismuth subsalicylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Bismuth subsalicylate is a OTC antacid that is FDA approved for the treatment of diarrhea, heartburn, indigestion, nausea, upset stomach. Common adverse reactions include darkening of the stool and/or tongue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

relieves:

diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

DIRECTIONS chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration which may accompany diarrhea. Other information: each tablet contains: sodium less than 1 mg salicylate 102 mg calcium 140 mg very low sodium avoid excessive heat (over 104˚F or 40˚C) TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bismuth subsalicylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bismuth subsalicylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Directions

• children 12 years and over: 2 tablets every 1/2 to 1 hour as needed

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bismuth subsalicylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bismuth subsalicylate in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Bismuth subsalicylate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Bismuth subsalicylate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bismuth subsalicylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bismuth subsalicylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bismuth subsalicylate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Bismuth subsalicylate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Bismuth subsalicylate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Bismuth subsalicylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bismuth subsalicylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bismuth subsalicylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bismuth subsalicylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bismuth subsalicylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bismuth subsalicylate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Bismuth subsalicylate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Bismuth subsalicylate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Bismuth subsalicylate in the drug label.

Pharmacology

There is limited information regarding Bismuth subsalicylate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Bismuth subsalicylate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Bismuth subsalicylate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Bismuth subsalicylate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Bismuth subsalicylate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Bismuth subsalicylate in the drug label.

How Supplied

Storage

There is limited information regarding Bismuth subsalicylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Bismuth subsalicylate in the drug label.

Precautions with Alcohol

• Alcohol-Bismuth subsalicylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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