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Anti-Diarrheal Tablet

Package insert / prescribing information
Generic name: loperamide hydrochloride
Dosage form: tablet
Drug class: Antidiarrheals

Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.

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
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 2-5 years (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20º-25ºC (68º-77ºF)
  • 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 REV0619D37508

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

Quality Plus 44-375

ANTI-DIARRHEAL
loperamide hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
Product Characteristics
Color green (light) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 44;375
Contains
Packaging
# Item Code Package Description
1 NDC:50844-375-02 3 BLISTER PACK in 1 CARTON
1 4 TABLET in 1 BLISTER PACK
2 NDC:50844-375-08 4 BLISTER PACK in 1 CARTON
2 6 TABLET in 1 BLISTER PACK
3 NDC:50844-375-45 1 BLISTER PACK in 1 CARTON
3 6 TABLET in 1 BLISTER PACK
4 NDC:50844-375-95 2 BLISTER PACK in 1 CARTON
4 6 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 05/03/2005
Labeler - L.N.K. International, Inc. (038154464)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack(50844-375)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack(50844-375)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture(50844-375)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack(50844-375)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack(50844-375)
L.N.K. International, Inc.

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