Tamsulosin Hydrochloride (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 0.4 mg Capsule Bottle Label

Tamsulosin
Hydrochloride
Capsules

0.4 mg*

Rx only

PRINCIPAL DISPLAY PANEL -- 0.4 mg Capsule Bottle Label
(click image for full-size original)
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4437(NDC:0115-8211)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SUCROSE
STARCH, CORN
DIBUTYL SEBACATE
MAGNESIUM STEARATE
TALC
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2)
COPOVIDONE
SILICON DIOXIDE
TITANIUM DIOXIDE
GELATIN
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C GREEN NO. 3
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color ORANGE (bright orange opaque) , GREEN (light green opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code G821
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4437-0 10 CAPSULE (CAPSULE) in 1 BOTTLE None
2 NDC:54868-4437-1 90 CAPSULE (CAPSULE) in 1 BOTTLE None
3 NDC:54868-4437-2 30 CAPSULE (CAPSULE) in 1 BOTTLE None
4 NDC:54868-4437-3 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090377 03/10/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 08/2011 Physicians Total Care, Inc.

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