Colace is a stool softener. It makes bowel movements softer and easier to pass.

Colace is used to treat or prevent occasional constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.

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

You should not use Colace if you have a blockage in your intestines.

Do not use Colace while you are sick with nausea, vomiting, or severe stomach pain.

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

Use Colace exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking this medicine.

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

Colace 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 this medicine for longer than 1 week, unless your doctor tells you to. Call your doctor if your symptoms do not improve, or if you have not had a bowel movement within 1 to 3 days. Overuse of a stool softener can lead to serious medical problems.

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

Usual Adult Dose for Constipation:

50 to 300 mg daily divided in 1 to 4 doses each day.

Usual Pediatric Dose for Constipation:

Less than 2 years: Check with your doctor.

2 to 12 years: 50 to 150 mg daily divided in 1 to 4 doses each day.

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

Ask a doctor or pharmacist if this medicine 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 Colace 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 to Colace : hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine 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

• if a rash occurs.

Less serious Colace 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 interact with docusate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

The liquid and capsule forms of docusate typically take about one to two days to work. Docusate enemas usually take effect within 20 minutes.

It’s best to use this medicine only for short periods of time. Let your doctor know if you’re still constipated after one week.

Your dosage will depend on the formulation of docusate you use and other factors.

Follow the instructions on the label carefully.

Your doctor may recommend docusate for other uses. For example, it’s sometimes given to empty the bowels before an X-ray of the stomach.