trol acetate) oral suspension between 15º to 25º C (59º to 77º F) and dispense in a tight container. Protect from heat.
SPECIAL HANDLING
Health Hazard Data
There is no threshold limit value established by OSHA, NIOSH, or ACGIH.
Exposure or overdose at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS sections). Women at risk of pregnancy should avoid such exposure.
Manufactured by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, New York 10977
Revised: 05/08 OS939-51-1-03
Megace ® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
PRINCIPAL DISPLAY PANEL
MEGACE ES PACKAGE LABEL
INGREDIENTS AND APPEARANCE
MEGACE ES
megestrol acetate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-254(NDC:49884-949)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEGESTROL ACETATE (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M) MEGESTROL ACETATE 125 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16590-254-33 150 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021778 06/08/2005
