Docusate

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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
Docusate is a OTC Laxative that is FDA approved for the treatment of constipation.   Common adverse reactions include Stomach pain, diarrhea, or cramping.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

### Dosage
- As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (12 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

## Off-Label Use and Dosage (Adult)

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

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### Dosage
- As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (12 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

## Off-Label Use and Dosage (Pediatric)

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

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

# Contraindications
There is limited information regarding Contraindications of Docusate in the drug label.

# Warnings
- Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel move- ment after the use of a laxative may indicate a serious condition. Discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

# Adverse Reactions

## Clinical Trials Experience
Stomach pain, diarrhea, or cramping

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

# Drug Interactions
- Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

# 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 Docusate in women who are pregnant.

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

### Nursing Mothers
There is no FDA guidance on the use of Docusate with respect to nursing mothers.

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

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

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Oral

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

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

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

# Pharmacology

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

## Structure
- Each 5 mL (teaspoonful) contains docusate sodium 50 mg.
- Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
- Sodium Content: 14 mg/5 mL.

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

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

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

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

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

## Storage
- Keep tightly closed. Store at controlled room temperature, 20 to 25C (68 to 77F). Protect from freezing. Protect from light.

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL
Docusate Sodium Liquid
100 mg/ 10mL
Stool Softener Laxative
5 Cups

### Ingredients and Appearance

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

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

# Brand Names
- DOCUSATE SODIUM

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

# Drug Shortage Status

# Price