Sodium borate

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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
Sodium borate is a OTC pellet that is FDA approved for the treatment of Canker sores (mouth ulcers).   Common adverse reactions include vomiting and diarrhoea, abdominal pain, rash.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- Canker sores (mouth ulcers)

### Dosage
- Directions: (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium borate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Sodium borate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Indications
- Canker sores (mouth ulcers)

### Dosage
- Directions: (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium borate in pediatric patients.

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

# Contraindications
There is limited information regarding Sodium borate Contraindications in the drug label.

# Warnings
- Stop use and ask a physician if symptoms persist for more than 3 days or worsen.
- Keep out of reach of children.
- Do not use if pellet-dispenser seal is broken.

# Adverse Reactions

## Clinical Trials Experience
- vomiting and diarrhoea, abdominal pain, rash

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium borate in the drug label.

# Drug Interactions
There is limited information regarding Sodium borate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- If pregnant or breast-feeding, ask a health professional before use.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium borate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Sodium borate during labor and delivery.

### Nursing Mothers
- If pregnant or breast-feeding, ask a health professional before use.

### Pediatric Use
There is no FDA guidance on the use of Sodium borate with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Sodium borate with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Sodium borate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Sodium borate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Sodium borate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Sodium borate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sodium borate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Sodium borate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Sodium borate in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Sodium borate in the drug label.

# Overdosage
There is limited information regarding Overdose of Sodium borate in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Sodium borate Mechanism of Action in the drug label.

## Structure
- Active Ingredient:
- Inactive Ingredients: Lactose, sucrose.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Sodium borate in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Sodium borate in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Sodium borate in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Sodium borate in the drug label.

# How Supplied
There is limited information regarding Sodium borate How Supplied in the drug label.

## Storage
- Store at room temperature.

# Images

## Drug Images

## Package and Label Display Panel

### Ingredients and Appearance

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Sodium borate in the drug label.

# Precautions with Alcohol
- Alcohol-Sodium borate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- BORAX

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

# Drug Shortage Status

# Price