Docusate is a stool softener that makes bowel movements softer and easier to pass.

Docusate is used to relieve occasional constipation (irregularity).

There are many brands and forms of docusate available. Not all brands are listed on this leaflet.

Docusate may also be used for purposes not listed in this medication guide.

You should not use docusate if you also use mineral oil, unless your doctor tells you to.

Use exactly as directed on the label, or as prescribed by your doctor.

Drink plenty of liquids while you are using docusate.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not take the rectal enema by mouth. Rectal medicine is for use only in the rectum.

Wash your hands before and after using the enema.

To use the enema, lie on your left side with your left leg extended and your right leg slightly bent. Remove the cap from the applicator tip and gently insert the tip into your rectum. Slowly squeeze the bottle to empty the contents into the rectum.

After using the enema, lie down on your left side for at least 30 minutes to allow the liquid to distribute throughout your intestines. Avoid using the bathroom, and hold in the enema at least 1 hour, or all night if possible.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Docusate generally produces bowel movement in 12 to 72 hours. Call your doctor if your symptoms do not improve after 72 hours.

You should not use docusate for longer than 1 week, unless your doctor tells you to.

Store at room temperature away from moisture, light, and heat. Do not freeze liquid medicine.

Usual Adult Dose for Constipation:

Oral: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.

Rectal: 200 to 283 mg rectally administered as an enema once or twice.
Alternative: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.

Usual Pediatric Dose for Constipation:

Oral:
less than 3 years: 10 to 40 mg (docusate sodium) orally divided in 1 to 4 doses.

3 to 6 years: 20 to 60 mg (docusate sodium) orally divided in 1 to 4 doses.

6 to 12 years: 40 to 150 mg (docusate sodium) orally divided in 1 to 4 doses.

greater than 12 years: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.

Rectal:
3 to 18 years: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.
Alternative: 200 to 283 mg rectally administered as an enema once daily as needed for constipation.

You should not use docusate if you are allergic to it.

Ask a doctor or pharmacist if docusate is safe to use if you have:

• stomach pain;

• nausea;

• vomiting; or

• a sudden change in bowel habits that lasts over 2 weeks.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Since docusate is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid using mineral oil, unless told to do so by a doctor.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using docusate and call your doctor at once if:

• you have rectal bleeding;

• no bowel movement occurs after using a laxative;

• you need to use a stool softener for more than 1 week; or

• rash occurs.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect docusate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.