SPL Set ID: d12cc802-b538-4065-a264-f474ff3b3043

Mannitol Injection 20%, USP is a sterile, nonpyrogenic solution of Mannitol, USP in 250 mL and 500 mL single-dose EXCEL ® flexible containers for intravenous administration as an osmotic diuretic. It contains no antimicrobial agents. Mannitol is a six-carbon sugar alcohol prepared commercially by the reduction of dextrose. Each 100 mL contains: Mannitol USP 20 g; Water for Injection USP qs pH: 5.3 (4.5-7.0); Calculated Osmolarity 1100 mOsmol/liter Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Mannitol USP 182.17 The EXCEL ® plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. molecular formula illustration