Peri-Colace

You should not use this medication if you are allergic to docusate and senna, or if you are also taking mineral oil.

Ask a doctor or pharmacist about using docusate and senna if you have:

• nausea or vomiting;

• stomach pain;

• a sudden change in bowel habits that lasts for 2 weeks or longer; or

• if you have an intestinal disorder such as Crohn's disease or ulcerative colitis.

Do not use this medication without your doctor's advice if you are pregnant.

It is not known whether docusate and senna passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ask a doctor before giving this medication to a child younger than 2 years old.

Do not use any other over-the-counter laxatives or other stool softener without first asking your doctor or pharmacist. Docusate or senna may be contained in other medicines available over the counter. If you take certain products together you may accidentally take too much of a certain medicine. Read the label of any other medicine you are using to see if it contains docusate or senna.

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

Stop using docusate and senna and call your doctor at once if you have a serious side effect such as:

• rectal bleeding;

• severe stomach pain, nausea, vomiting; or

• no bowel movement.

Less serious side effects may include:

• gas, bloating;

• diarrhea; or

• mild nausea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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.

• Store at room temperature.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Peri-Colace, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Peri-Colace (docusate and senna). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Peri-Colace.

Review Date: October 4, 2017

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to docusate / senna: oral tablet

Gastrointestinal

Gastrointestinal side effects of docusate have included gastrointestinal cramping.

Gastrointestinal side effects of senna have included esophageal impaction and duodenal bezoars. These effects have been reported in patients receiving a bulk laxative product containing 82% psyllium and 18% senna (commercially available as Perdiem Overnight Relief).[Ref]

Hypersensitivity

One case has been reported involving a factory worker who developed IgE-mediated asthma and rhinoconjunctivitis five months after exposure to senna.[Ref]

Hypersensitivity side effects of senna have rarely included occupational sensitization to senna.[Ref]

Metabolic

Metabolic side effects of docusate 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]

Musculoskeletal

Musculoskeletal side effects of senna have rarely included finger clubbing.[Ref]

Dermatologic

Dermatologic side effects of docusate have included rash.[Ref]

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