ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled 
Freds Inc

----------

Drug Facts

Active Ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti- diarrheal

Use

controls symptoms of diarrhea, including Traveler's 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 gets 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 Certer right away. 

Directions

Other information

Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.

Questions or comments?

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

Principal Display Panel

Anti-Diarrheal

Loperamide HCl, 2mg

Controls the symptoms of diarrhea

Suitable For Adults And Children 12 Years And Over

SOFTGELS**

**each liquid-capsule contains 2 mg Loperamide HCl

Compare To The Active Ingredients in 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.

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

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

Loperamide HCI 2 mg

Fred's Pharmacy Anti-Diarrheal

ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-520
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 10mm
Flavor Imprint Code P13
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-520-24 2 in 1 CARTON 07/08/2010
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 07/08/2010
Labeler - Freds Inc (005866116)

Revised: 8/2016
Document Id: d8bce7fb-d709-4da9-927e-346e27bc7fac
Set id: 984f0b01-cc7b-4ca1-9299-fd031cbc94bf
Version: 3
Effective Time: 20160822
 
Freds Inc