Bismuth subsalicylate

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

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

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

# Warnings
- Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product , if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
- Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
- Do not use if you have
- bloody or black stools
- an ulcer
- a bleeding problem
- Ask a doctor before use if you have
- fever
- mucus in the stool
- Ask a doctor or pharmacist before use if you aretaking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
- When using this product
- a temporary, but harmless darkening of the stool and/or tongue may occur.
- Stop use and ask a doctor if
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

# Adverse Reactions

## Clinical Trials Experience
darkening of the stool and/or tongue

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

# Drug Interactions
There is limited information regarding Bismuth subsalicylate Drug Interactions in the drug label.

# 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

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

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

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

# Pharmacology

## Mechanism of Action
There is limited information regarding Bismuth subsalicylate Mechanism of Action in the drug label.

## Structure

### ACTIVE INGREDIENT (IN EACH TABLET)=
- Bismuth subsalicylate 262 mg
- (total salicylate 102 mg per tablet)
- calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

## 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
There is limited information regarding Bismuth subsalicylate How Supplied in the drug label.

## Storage
- avoid excessive heat (over 104 F or 40 C)

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL

### Ingredients and Appearance

# 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
- BISMATROL

# Look-Alike Drug Names
There is limited information regarding Bismuth subsalicylate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price