The ASMANEX TWISTHALER product is comprised of an assembled plastic cap-activated dosing mechanism with dose counter, drug-product storage unit, drug-product formulation (240 mg), and mouthpiece, covered by a white screw cap which 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 # 0085-1341-04); 30 inhalation units (NDC # 0085-1341-03); 60 inhalation units (For more than one inhalation daily; NDC # 0085-1341-02); or 120 inhalation units (For more than 2 inhalations daily; NDC # 0085-1341-01).
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.
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