Loperamide Hydrochloride (Page 5 of 5)

HOW SUPPLIED

Loperamide hydrochloride capsules USP, 2 mg are available as:

A light brown opaque body and dark brown opaque capsule, imprinted “TEVA” on the cap and “0311” on the body and packaged in bottles of 100 (NDC 0093-0311-01) and 500 (NDC 0093-0311-05).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Czech Republic By:

Teva Czech Industries, s.r.o.

Opava-Komarov, Czech Republic

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. Q 11/2016

Package/Label Display Panel

NDC 0093-0311-01

LOPERAMIDE

HYDROCHLORIDE

Capsules, USP

2 mg

Rx only

100 CAPSULES

1
(click image for full-size original)

LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color brown (light and dark brown) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code TEVA;0311
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0311-01 100 CAPSULE in 1 BOTTLE None
2 NDC:0093-0311-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073192 05/01/1993
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2016 Teva Pharmaceuticals USA, Inc.

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