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 15 (NDC 70934-546-15)

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

Principal Display Panel

NDC: 70934-546-15

LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-546(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:70934-546-15 15 CAPSULE in 1 BOTTLE, PLASTIC None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073192 02/06/2020

Labeler — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Registrant — Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Establishment
Name	Address	ID/FEI	Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals		080355546	repack (70934-546)

Revised: 02/2020 Denton Pharma, Inc. dba Northwind Pharmaceuticals