Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

Inclusion Criteria: * Signed informed consent from one of the parent(s)/legal representative(s) * Subjects, both genders, aged 3 to 60 months * Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days) Exclusion Criteria: * Known allergy to Racecadotril or any of its ingredients * Subjects suffering from renal or hepatic impairment * Subjects with fever \> 39 degrees Celsius * Subjects with bloody and/or purulent stools * Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea * Subjects with alternating bouts of diarrhea and constipation * Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency * Cystic fibrosis or coeliac disease * Subjects suffering from prolonged or uncontrolled vomiting * Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency * Subjects having received antibiotic treatment at any time within 2 weeks prior to inclusion into the study * Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study * Subjects with severe dehydration requiring intravenous fluid, electrolyte replacement or hospitalization treatment * Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) * Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator * Intake of experimental drug within 30 days prior to study start * Subjects with contraindications to ORS or susceptible to the warnings of ORS