Step 23: Place the lid back on the storage case base and screw the cover in a clockwise direction until it is tight (See Figure V).
Figure V

How should I store TOBI Podhaler?

Store your Podhaler device and blister-packaged capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the TOBI Podhaler capsules and Podhaler device in a dry place.
Store the Podhaler device tightly closed in its case when you are not using it.
Keep TOBI Podhaler capsules, Podhaler device, and all medicines out of the reach of children.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, NJ 07936

© Novartis

T2013-22
March 2013
PRINCIPAL DISPLAY PANEL

Package Label – 28 mg per capsule

Rx Only NDC 0078-0630-35

TOBI™ Podhaler™

(tobramycin inhalation powder)

28 mg per capsule

4 weekly packs x 56 capsules per pack

For Oral Inhalation Only

Do not swallow TOBI® Podhaler™ capsules

TOBI® Podhaler™ capsules are for use with the Podhaler™ device only

Contents:
4 weekly packs, each containing:
56 capsules (7 blister cards of 8 capsules)
1 Podhaler™ device
Patient information leaflet
1 Reserve Podhaler™ device
Prescribing Information
TOBI PODHALER
tobramycin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0630
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule  
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 28 mg
 
Inactive Ingredients
Ingredient Name Strength
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE  
CALCIUM CHLORIDE  
SULFURIC ACID  
 
Product Characteristics
Color WHITE (clear, colorless) Score no score
Shape CAPSULE Size 18mm
Flavor   Imprint Code NVR;AVCI
Contains  
 
Packaging
# Item Code Package Description
1 NDC:0078-0630-35 224 in 1 BOX, UNIT-DOSE
1 NDC:0078-0630-56 56 in 1 PACKAGE
1 NDC:0078-0630-11 4 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201688 03/22/2013  
 
Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 03/2013
Document Id: ff8c7c8d-7396-4e03-b84e-efadb3e28cd0
Set id: 625a4499-4e46-4f5a-8d0c-d104f520d97e
Version: 1
Effective Time: 20130322· ·OSPHENA (ospemifene) tablet