Enemeez Mini oral / rectal

You should not use docusate if you are allergic to it, or if you have:

• nausea, vomiting, or severe stomach pain;

• a blockage in your intestines; or

• chronic stomach pain that has not been checked by a doctor.

You should not take mineral oil while using docusate.

Ask a doctor or pharmacist if it is safe for you to take docusate:

• if you are on a low-salt diet; or

• if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

FDA pregnancy category C. It is not known whether docusate will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether docusate passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 years old without the advice of a doctor.

Since docusate is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these 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:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• rectal bleeding or irritation;

• numbness or a rash around your rectum;

• vomiting, severe diarrhea or stomach cramps; or

• continued constipation, or no bowel movement.

Common side effects may include:

• dizziness, weakness;

• gas, bloating, mild diarrhea;

• rectal irritation; or

• sweating.

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.

Applies to docusate: oral capsule, oral liquid, oral syrup, oral tablet

Other dosage forms:

• rectal enema

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to docusate: compounding powder, oral capsule, oral liquid, oral syrup, oral tablet, rectal enema

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal cramping. Reports of bitter taste and throat irritation have been reported with administration of primarily the syrup and liquid formulations.[Ref]

Dermatologic

Dermatologic side effects have included rash.[Ref]

Metabolic

Metabolic side effects have included at least one case report of hypomagnesemia.[Ref]

Metabolic abnormalities reported include hypomagnesemia in one woman who took docusate chronically throughout her pregnancy. Magnesium levels returned to normal following discontinuation of docusate.[Ref]

Some side effects of Enemeez Mini may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.