HOW SUPPLIED/STORAGE AND HANDLING
The ASMANEX TWISTHALER 220 mcg product is comprised of an assembled plastic cap–activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (135 mg for the 14 and 30 inhalation units and 240 mg for the 60 and 120 inhalation units), and mouthpiece, covered by a white screw cap that bears the product label. The body of the inhaler is white and the turning grip is pink with a clear plastic window indicating the number of doses remaining. The inhaler will not deliver subsequent doses once the counter reaches zero ("00").
The ASMANEX TWISTHALER product is available as:
ASMANEX TWISTHALER 220 mcg, which delivers 200 mcg mometasone furoate from the mouthpiece:
14 inhalation units (Institutional Use Only; NDC# 54868-5547-2);
30 inhalation units (NDC# 54868-5547-1);
60 inhalation units (For more than 1 inhalation daily; NDC# 54868-5547-0).
Each inhaler is supplied in a protective foil pouch with Patient's Instructions for Use.
Store in a dry place at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Discard the inhaler 45 days after opening the foil pouch or when dose counter reads "00", whichever comes first.