ANTI DIARRHEAL- loperamide hcl tablet 
Harmon Store Inc.

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Core Values 44-375-Delisted

Active ingredient (in each caplet)

Loperamide HCl 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. 

Ask a doctor before use if you have

  • a 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 (1-800-222-1222) right away. 

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose on chart. If possible, use weight to dose: otherwise, use age.

 adults and children
 12 years and over

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 the 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

  • use by expiration date on package
  • store between 20º-25ºC (68º-77ºF) 

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

CORE VALUES™

*Compare to active ingredient in Imodium® A-D

NDC 63940-375-19

Anti-Diarrheal
Loperamide HCl 2 mg

Anti-Diarrheal
Controls the symptoms of diarrhea

Actual Size

8 caplets

TAMPER EVIDENT: Use Only if This Blister is Intact

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Imodium® A-D.
50844        ORG071537519

Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Distributed by:
Liberty Procurement, Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

Core Values 44-375

Core Values 44-375

ANTI DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-375
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
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-375-191 in 1 PACKAGE05/03/200502/03/2019
18 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/200502/03/2019
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63940-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63940-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63940-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63940-375)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63940-375)

Revised: 2/2020
Document Id: 10577dcc-e229-46e8-a115-42c73879a69b
Set id: 4c08b812-378d-4707-8603-0c0776958dff
Version: 7
Effective Time: 20200213
 
Harmon Store Inc.