SIDE EFFECTS: See also Precautions for side effects seen in children. Drowsiness, dizziness, headache, tiredness, blurred vision, dry mouth, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: stomach/abdominal pain or swelling, severe nausea, vomiting, mental/mood changes (e.g., confusion, depression), restlessness, numbness/tingling of arms/legs. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

PRECAUTIONS: Before taking difenoxin with atropine, tell your doctor or pharmacist if you are allergic to either drug; or to hyoscyamine; 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., obstructive jaundice, cirrhosis), diarrhea caused by certain types of infections (Clostridium difficile-associated diarrhea following recent antibiotic therapy, bacterial infection of the gut caused by E. coli, Salmonella, Shigella). Before using this medication, tell your doctor or pharmacist your medical history, especially of: current dehydration or mineral imbalance, a certain type of bowel disease (acute ulcerative colitis), personal or family history of glaucoma (angle-closure type). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This drug is not recommended for use in children younger than 2 years. Caution is advised when using this drug in children, particularly those with Down's syndrome, because they may be more sensitive to the following side effects: high fever, fast heartbeat, decreased urination, flushing, dry skin/mouth, thirst. Very serious (possibly life-threatening) effects may occur if too much of this medication is taken by children. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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: ambenonium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), naltrexone, potassium tablets/capsules, pramlintide. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, 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.

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, muscle weakness, fast heartbeat, high fever, unusually fast/slow/irregular breathing, seizures, loss of consciousness.