NDC 54868-5442-1 Bottle of 90

Store at 25°C (77°F)

Excursions permitted to 15-30 °C (59-86 °F)

[see USP Controlled Room Temperature]

Manufactured for

Shire US Inc., One Riverfront Place, Newport, KY, 41071, USA

by NYCOMED Austria GmbH

© 2003 Shire US Inc.

Rev. 10/03

003 0107 006

Rx only

Repackaging and Relabeling by:
Physicians Total Care, Inc.
Tulsa, OK       74146

PRINCIPAL DISPLAY PANEL
ProAmatine®
5 mg

PROAMATINE 
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:54868-5442(NDC:54092-004)
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE)  MIDODRINE HYDROCHLORIDE 5 mg
 
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
STARCH, CORN  
FD&C YELLOW NO. 6  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TALC  
 
Product Characteristics
Color orange (orange)  Score 2 pieces
Shape ROUND (Round)  Size 7mm
Flavor  Imprint Code RPC;5;004 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:54868-5442-0 10 in 1 BOTTLE
2 NDC:54868-5442-1 90 in 1 BOTTLE
3 NDC:54868-5442-2 60 in 1 BOTTLE

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019815 09/30/2005 

Labeler - Physicians Total Care, Inc. (194123980) 
Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc.  194123980 repack, relabel

Revised: 05/2010
Document Id: ca6a9e8a-2cba-4775-8131-cb8d8db28ea8Set id: 9e8874f0-ad2e-41ce-8a35-bed819615a5dVersion: 1Effective Time: 20100526
Physicians Total Care, Inc.