SPL Set ID: 1eaa7790-f1a1-4f51-b10a-cbbaf033f684

CALDOLOR (ibuprofen injection) is a nonsteroidal anti-inflammatory drug, available as an 800 mg/8 mL single dose vial (100 mg/mL) and 800 mg/200 mL (4 mg/mL) polypropylene, single dose, ready-to-use, flexible bag for intravenous administration. The chemical name is ibuprofen, which is (±)-2-( p -isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74°C to 77°C. It has a molecular weight of 206.28. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is represented below: Structural Formula of Ibuprofen CALDOLOR 800 mg/8 mL (100 mg/mL) vial: Each 1 mL of solution contains 100 mg of ibuprofen, USP, 78 mg of arginine (at a molar ratio of 0.92:1 arginine:ibuprofen), and 10% arginine solution and hydrochloric acid as pH adjusters in Water for Injection, USP. The solution pH is about 7.4. CALDOLOR 800 mg/200 mL (4 mg/mL) polypropylene flexible bag: Each 1 mL of solution contains 4 mg of ibuprofen, USP, 3.11 mg of dibasic sodium phosphate, as a buffering agent; 6.30 mg sodium chloride as a tonicity agent; and sodium hydroxide as a pH adjuster in Water for Injection, USP. The solution is iso-osmotic with an approximate pH of 7.4. CALDOLOR is sterile and is intended for intravenous administration only.