Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Labeler
- Kesin Pharma Corporation
- Label updated
- 2026-06-30
- Retrieved
- 2026-09-07
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
Active ingredient (in each 7.5 mL)
Loperamide HCl, USP 1 mg
Purpose
Anti-Diarrheal
Uses
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
- 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 right away. (1-800-222-1222)
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.
- shake well before using
mL = milliliter
| adults and children 12 years and over | 30 mL after the first loose stool; 15 mL after each
subsequent loose stool; but no more than 60 mL in 24 hours |
|
| children 9 years to 11 years
(60 lbs to 95 lbs) |
15 mL after first loose stool; 7.5 mL after each subsequent
loose stool; but no more than 45 mL in 24 hours |
|
| children 6 years to 8 years
(48 lbs to 59 lbs) |
15 mL after first loose stool; 7.5 mL after each subsequent
loose stool; but no more than 30 mL in 24 hours |
|
| children 2 years to 5 years
(34 lbs to 47 lbs) |
ask a doctor | |
| children under 2 years
(up to 33 lbs) |
do not use |
Other information
- each 30 mL contains: sodium 7 mg
- store at 20°C to 25°C (68°F to 77°F)
- Loperamide HCl Oral Solution is a light green opaque, cool mint flavored solution supplied in the following:
NDC 81033-067-07: 7.5 mL unit-dose cup
NDC 81033-067-34: Carton containing 30 unit-dose cups of 7.5 mL each
NDC 81033-067-15: 15 mL unit-dose cup
NDC 81033-067-35: Carton containing 30 unit-dose cups of 15 mL each
Inactive ingredients
anhydrous citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavadew coolmint flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, plain caramel powder, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum
Questions or comments?
Call 1-616-218-2725
*This product is not manufactured or distributed by the owners of Imodium ®A-D.
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-067-V01
Rev. 05/2026
[Image in the official label — see DailyMed source]
PRINCIPAL DISPLAY PANEL
NDC 81033-067-34
Loperamide Hydrochloride Oral Solution, USP
1 mg per 7.5 mL
Delivers 7.5 mL
30 x 7.5 mL Unit Dose Cups
[Image in the official label — see DailyMed source]
포장 표시
NDC 81033-067-35
Loperamide Hydrochloride Oral Solution, USP
2 mg per 15 mL
Delivers 15 mL
20 x 15 mL Unit Dose Cups
[Image in the official label — see DailyMed source]
DailyMed Set ID: 52e6ecc5-5f3d-9989-e063-6294a90af2dc · Version 1
NDC: 81033-067