Loperamide Hydrochloride
- Dosage form
- TABLET
- Labeler
- Preferred Pharmaceuticals Inc.
- Label updated
- 2026-05-28
- Retrieved
- 2026-09-07
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
Drug Facts
Active ingredient (in each tablet)
Loperamide hydrochloride USP 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 hydrochloride
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
-
• 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours |
|
children 9 to 11 years (60 to 95 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours |
|
children 6 to 8 years (48 to 59 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours |
|
children 2 to 5 years (34 to 47 lbs) |
ask a doctor |
|
children under 2 years (up to 33 lbs) |
do not use |
Other information
-
• store at 20° to 25°C (68° to 77°F). -
• do not use if carton or blister unit is open or torn -
• Meets USP dissolution test 2 -
• See side panel for lot number and expiration date
Inactive ingredients
colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Questions or comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code .: TS/DRUGS/22/2009
Relabeled By: Preferred Pharmaceuticals Inc.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)
AUROHEALTH
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8393
*Compare to the active
ingredient of Imodium® A-D
Loperamide Hydrochloride
Tablets USP 2 mg
Anti-Diarrheal
Controls the symptoms of diarrhea
24 Tablets
[Image in the official label — see DailyMed source]
DailyMed Set ID: 5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf · Version 5
NDC: 68788-8393