A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketingsurveillance to evaluate the Safety and Efficacy of Wikoryl Oral Suspension in children ofcommon cold with fever or allergic rhinitis

It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and efficacy of Wikoryl Oral Suspension, FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 1 mg, per 5 ml in children suffering from Common cold with fever or allergic rhinitis. The active PMS will be conducted for the duration of 5 days by the investigator. At day 1 (baseline) the patient’s guardian will be informed about the study procedure and if agreed then his/ her sign on the informed consent form will be taken and patient will be recruited for the active PMS of Wikoryl Oral suspension. Based on the prescription of the principle investigator the guardians of the patient will give the patient the required medication for the period of 5 days starting from day 1 (visit 1). Also patient’s guardians will be asked to visit to the clinical trial site along

with the patient at day 6 for safety and efficacy assessment. Symptom assessment at baseline and visit 2, will be done by principle investigator by measuring the symptom scores for fever, rhinorrhea, nasal congestion and sneezing on a four-point Likert scale for intensity (severity): 0= no symptom, 1 = mild, 2= moderate and 3= severe. Fever is characterized as 0= No fever (< 100.4), 1=Mild/low-grade fever (100.5–102.2 F) ,2=Moderate grade fever (102.2–104.0 F), 3= High grade fever High-grade (104.1–106.0 F).