ANTI-DIARRHEAL- loperamide hydrochloride capsule 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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Healthcare 44-375

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Antidiarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

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

Do not use

 if you have bloody or black stool

Ask a doctor before use if you have

  •  high 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 buldging. 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

adults and children 12 years and older 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
 children 9-11 years (60-95 lbs)1 caplet after first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)ask a doctor

Other information

Inactive ingredients

corn starch, D&C yellow # 10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

HEALTHCARE
NDC 64092-105-12

Anti-Diarrheal
Loperamide Hydrochloride Caplets, 2 mg

Controls the Symptoms of Diarrhea

Compare to the active ingredient in Imodium® A-D Caplets*

12 CAPLETS

* This product is not manufactured or distributed by Schering-Plough HealthCare Products, owner of the registered trademark Correctol®.
50844    REV1212G37502

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Healthcare 44-375

Healthcare 44-375


ANTI-DIARRHEAL 
loperamide hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64092-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorGREENScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-105-121 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(64092-105)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(64092-105)

Revised: 6/2013
Document Id: f4d95dd5-c95f-48c7-b779-dbe9a3814938
Set id: 23c80369-7446-4b30-bb15-0043916b7c7c
Version: 2
Effective Time: 20130628
 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.