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

----------

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

  • if you have bloody or black stool
  • in children under 12 years of age 

Ask a doctor before use if you have

  •  fever
  • mucus in the stool
  • a history of liver disease

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 a doctor if

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition. 

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, FD&C blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM® A-D

Anti-Diarrheal

Loperamide HCI

Soft Gelatin Capsules, 2 mg

Controls the Symptoms of Diarrhea

Suitable for adults and children 12 years and over

Softgels**

**each liquid-filled capsule

contains 2 mg loperamide HCI

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, Distributor of Imodium® A-D

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

www.emersongroup.com

Product Labeling

Loperamide HCI 2 mg

PREMIER VALUE Anti-Diarrheal

LOPERAMIDE HCL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-193
Route of Administration ORAL
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 MONOCAPRYLATE (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 12/04/2012
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
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: 8/2016
Document Id: 8f797057-4053-4c4c-b863-51d83d851077
Set id: 4e1ea9c9-031f-4b78-ac21-27bdc7683139
Version: 4
Effective Time: 20160818
 
Chain Drug Consortium, LLC