LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled 
Chain Drug Consortium, LLC

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Premier Value Loperamide HCl Capsules

Active ingredient(in each capsule)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers'Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking antibiotics

When using this product

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Butylated hydroxyanisole, edible ink FDandC blue #1, Gelatin, Glycerin, Glyceryl Caprylate, Polyoxyl 40 hydrogenated castor oil and purified water.

Product Labeling

Premier Value
Compare to the active ingredient in Imodium(r) A-D

Anti-Diarrheal
Loperamide HCl
Soft gelatin capsules, 2mg

Controls the Symptoms of Diarrhea
suitable for adults and children 12 years and over

12 softgels

Distributed by: Chan Drug Consortium, LLC
3301 NW Boca Raton Blvd. Suite 101
Boca Raton, FL 33431

Manufactured by
Banner Pharmacaps, Inc.
4215 Premier Drive
High Point, NC 27265

**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of ther egistered trademark of Imodium (r) A-D.

Loperamide HCl

LOPERAMIDE HCL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-193
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code p13
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-193-12 2 in 1 BOX
1 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 12/04/2012
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2012
Document Id: 47bff05d-dc66-42fd-a9c2-c15d275167c7
Set id: 4e1ea9c9-031f-4b78-ac21-27bdc7683139
Version: 2
Effective Time: 20121205
 
Chain Drug Consortium, LLC