This medication is used to treat diarrhea. It helps to decrease how often you have bowel movements. It works by slowing the movement of the intestines. Opium belongs to a class of drugs known as opioid pain relievers, but this medication acts mainly to slow the gut.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

A very weak solution of this drug may also be used for severe withdrawal symptoms in infants born to mothers who were addicted to opioids during pregnancy.

Take this medication by mouth as directed by your doctor, usually 4 times daily. It may be taken with food or meals if stomach upset occurs.

Carefully measure each dose using the dropper provided. If your medication comes in an oral dosing syringe, use the syringe to measure the dose. Do not use a household spoon because you may not get the correct dose. Do not inject the medication. The dose may be mixed with a small amount of water just before taking.

The dosage is based on your medical condition and response to treatment.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as sweating, nausea, vomiting, restlessness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used opium for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for a long time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Diarrhea can sometimes cause dehydration. It is important that you drink the proper amount of fluids and electrolytes to prevent this effect. Tell your doctor right away if you develop signs of dehydration (such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information.

Tell your doctor if your condition lasts or gets worse after 2 to 3 days of treatment.

Nausea, vomiting, lightheadedness, dizziness, drowsiness, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as agitation, confusion, hallucinations)
• severe stomach/abdominal pain
• difficulty urinating

Get medical help right away if you have any very serious side effects, including:

• fainting
• seizure
• slow/shallow breathing
• severe drowsiness/difficulty waking up

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other opioids (such as codeine, morphine); or to papaverine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• brain disorders (such as head injury, tumor, seizures)
• breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD)
• kidney disease
• liver disease
• mental/mood disorders (such as confusion, depression)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus)
• difficulty urinating (such as due to enlarged prostate)
• disease of the pancreas (pancreatitis)
• gallbladder disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This product also contains alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially slow/shallow breathing.

Older adults may be more sensitive to side effects of this drug, especially slow/shallow breathing and drowsiness.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, crying that is unusual or doesn't stop, vomiting, or diarrhea.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• certain pain medications (mixed opioid agonist/antagonists such as pentazocine, nalbuphine, butorphanol)
• naltrexone

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slowed breathing, slow heartbeat, severe dizziness/drowsiness, fainting, muscle weakness.

Do not share this medication with others. Sharing it is against the law.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.