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Loperamide HCl by L.N.K. International, Inc.

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-735

Quality Plus 44-375 Loperamide HCl

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

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 over2 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

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

Principal Display Panel

QUALITY
+PLUS

NDC 50844-735-19

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

LOPERAMIDE HCl
TABLETS, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

8 Caplets

ACTUAL SIZE

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

1. To open, tear
at perforations and
remove a section.

2. Use ✄ to cut
through plastic
for caplet.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of
the registered trademark Imodium® A-D.                           50844           ORG041737519

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-375

LOPERAMIDE HCL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-735
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;375
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-735-451 BLISTER PACK in 1 CARTON
16 TABLET in 1 BLISTER PACK
2NDC:50844-735-192 BLISTER PACK in 1 CARTON
24 TABLET in 1 BLISTER PACK
3NDC:50844-735-461 BOTTLE, PLASTIC in 1 CARTON
396 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-735)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-735)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-735)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-735)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-735)

 
L.N.K. International, Inc.

← See all Loperamide HCl brands

Medically reviewed on Jun 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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