When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to difenoxin, atropine, or if you have jaundice (yellowing of your skin or eyes). You should not use this medicine if you have diarrhea caused by certain kinds of food poisoning or diarrhea caused by using antibiotics. Do not give this medicine to a child under 2 years of age.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much to use and how often.
• You should not use more of this medicine than your doctor ordered.
• Drink plenty of caffeine-free, clear liquids such as ginger ale, water, gelatin, or broth during the first 24 hours. You will need to replace the fluids your body loses when you have diarrhea.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you are using medicines that could make you drowsy such as sleeping pills, some cold or allergy medicine, strong pain killers, tranquilizers or muscle relaxants.
• Avoid drinking alcohol while using this medicine. You may get too drowsy or sedated if you drink alcohol or use medicines that cause drowsiness with difenoxin/atropine.
• Make sure your doctor knows if you are using a medicine called a monoamine oxidase (MAO) inhibitors. MAO inhibitors such as Parnate®, Marplan®, or Nardil® treat depression. Eldepryl® is used to treat Parkinson's disease. Using this medicine with a MAO inhibitor can cause severe high blood pressure.

Warnings While Using This Medicine:

• If you are pregnant, talk to your doctor before using this medicine. Do not breastfeed while using this medicine.
• Talk with your doctor before using this medicine if you have liver or kidney disease, ulcerative colitis, glaucoma, an enlarged prostate, trouble urinating, or a blocked intestine.
• This medicine may make you dizzy or drowsy. Avoid driving or using machinery until you know how the medicine will affect you.
• This medicine may be habit forming. Talk with your doctor about any drug addictions or addiction treatments you have received before you use this medicine.
• If you still have diarrhea after 2 days of using the medicine or if you get a fever, talk with your doctor.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Irregular or fast heartbeat
• Slow or decreased breathing, trouble breathing
• Swelling in your stomach

If you notice these less serious side effects, talk with your doctor:

• Drowsiness or dizziness
• Nausea
• Trouble urinating
• Dry mouth
• Blurred vision
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088