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

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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

Heart alert: Taking more than directed can cause serious heart problem or death

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

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

  • store at 20o-25o C (68o-77o F). Protect from light.
  • avoid excessive heat above 40°C (104°F).
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

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-FILLED CAPSULE CANTAINS 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 & Specialty Pharmaceuticals, distributor of Imodium® A-D.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD,,

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-520
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code P13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-520-242 in 1 CARTON07/08/201012/31/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185507/08/201012/31/2019
Labeler - Freds Inc (005866116)

Revised: 12/2018
Document Id: f71384f9-4865-4b88-963b-d81e578fb6d7
Set id: 984f0b01-cc7b-4ca1-9299-fd031cbc94bf
Version: 5
Effective Time: 20181212
 
Freds Inc