Tamsulosin Hydrochloride: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

67296-0802
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 COUNT LABEL
(click image for full-size original)

TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0802(NDC:0228-2996)
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
FERRIC OXIDE RED
WATER
TALC
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
SHELLAC
GELATIN
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
ALCOHOL
Product Characteristics
Color orange, green (olive colored cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TSL;0;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-0802-1 7 CAPSULE in 1 BOTTLE None
2 NDC:67296-0802-2 10 CAPSULE in 1 BOTTLE None
3 NDC:67296-0802-3 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078801 04/27/2010
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-0802), relabel (67296-0802)

Revised: 03/2021 RedPharm Drug, Inc.

Page 4 of 4 1 2 3 4

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.