Shipper Label (Simethicone Shipper Label Page 001)
Simethicone is a medication that comes in soft gelatin capsules with each capsule containing 250 mg of Simethicone USP. The capsules are intended for further processing, and the contents need approval, immediate repackaging, and labeling in strict conformance with the FD&C Act and Regulations thereunder. The capsules come in a bulk shipment of 48x1500 softgels and should be protected from direct sunlight, moisture, and freezing. The manufacturer is Medgel Private Limited located at Plot No. 19-20, Special Economic Zone-ll (Pharma Zone), Sector-1il, Pithampur, Distt. Dhar-454775, Madhya Pradesh, India, and the labeler code is 100 with an MFG. LIC. NO. of XHHO00CO0KHXXXNKKK. The medication warns against keeping it out of the reach of children and requires storage at a controlled temperature of 5¢°F o 86°F (15°C o 30°C).*