Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

Inclusion Criteria:

• Participant's symptoms of acute diarrhea must manifest within 48 hours prior toentering the trial

• Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool orsoft stool as determined after placing the stool in a container)

• Participant's most recently produced stool must be unformed stool

• Participant must give a positive answer to the following question: "Have you felt anyabdominal discomfort caused by gastrointestinal gas accumulation within the last hour"

• Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or bepostmenopausal

Exclusion Criteria:

• Participant hospitalized for treatment of severe acute diarrhea or otherwise requiresintravenous fluids or antibiotics on an outpatient basis

• Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) oran oral temperature > 38.6 degrees C

• Participant shows clinical symptoms of bloody or purulent stool or erythrocytes orleukocytes are detected in the participant's stool at > 3 per high power field

• Participant shows a sitting systolic blood pressure less than (<) 90 millimeter ofmercury (mmHg) and/ or diastolic blood pressure < 60 mmHg

• Participant is unable to take medication orally or tolerate oral rehydration