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Anti-diarrheal by L.N.K. International, Inc.

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-375

Quality Plus 44-375 Anti-diarrheal

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 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
  • 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 50844-375-08

*Compare to active ingredient
in Imodium® A-D

ANTI-
DIARRHEAL
Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

24 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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Imodium® A-D.
 50844           ORG0417C37508

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

Quality Plus 44-375

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-375
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 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREEN (light) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;375
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-375-023 BLISTER PACK in 1 CARTON
14 TABLET in 1 BLISTER PACK
2NDC:50844-375-084 BLISTER PACK in 1 CARTON
26 TABLET in 1 BLISTER PACK
3NDC:50844-375-451 BLISTER PACK in 1 CARTON
36 TABLET in 1 BLISTER PACK
4NDC:50844-375-008 BLISTER PACK in 1 CARTON
46 TABLET in 1 BLISTER PACK
5NDC:50844-375-952 BLISTER PACK in 1 CARTON
56 TABLET in 1 BLISTER PACK
6NDC:50844-375-221 BOTTLE, PLASTIC in 1 CARTON
648 TABLET in 1 BOTTLE, PLASTIC
7NDC:50844-375-231 BOTTLE, PLASTIC in 1 CARTON
772 TABLET in 1 BOTTLE, PLASTIC
8NDC:50844-375-461 BOTTLE, PLASTIC in 1 CARTON
896 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(50844-375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-375)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-375)

Revised: 11/2017
 
L.N.K. International, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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