HOW SUPPLIED
OMNARIS is supplied in an amber glass bottle and provides for
nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with
an oxygen absorber sachet and enclosed in a foil pouch. OMNARIS Nasal Spray
provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of
ciclesonide from the nasal actuator. The OMNARIS Nasal Spray bottle has been
filled with an excess to accommodate the priming activity. The bottle should be
discarded after removal from the foil pouch either after 120 sprays following
initial priming (since the amount of ciclesonide delivered per spray thereafter
may be substantially less than the labeled dose) or after 4 months. Patient
instructions are also provided.
OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. (NDC 54868-6020-0)
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP
Controlled Room Temp]. Do not freeze. Shake gently before use.
Do not spray in eyes. Keep out of reach of
children.
Manufactured for:
Sepracor Inc. Marlborough, MA 01752 USA
Made in Germany
For customer service, call 1-888-394-7377 To report adverse events, call
1-877-737-7226 For medical information, call 1-800-739-0565
November 2007
USA F.1/1207/3.5472.73
Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
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