PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to loperamide; or to simethicone; 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: stomach/abdominal pain without diarrhea, bowel obstruction (e.g., ileus, megacolon, abdominal distention).Antibiotics may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. Symptoms include: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool. This condition may occur weeks after antibiotic treatment has stopped. This medication may make this condition worse. Do not use this anti-diarrhea product, especially after recent antibiotic use, if you have the above symptoms without talking with your doctor first.This medication should not be used without seeing your doctor first if you have certain medical conditions. These symptoms/conditions may require other treatment before you can use this medication safely. Before using this medication, tell your doctor or pharmacist your medical history, especially of: black/tarry stool, blood/mucus in your stool, high fever, HIV infection/AIDS, liver problems, certain stomach/intestinal infections (e.g., Salmonella, Shigella), certain type of bowel disease (acute ulcerative colitis).This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially the drowsiness effect. Children are at higher risk for dehydration. (See also Uses, How to Use sections.)During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk but is unlikely to have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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