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Loperamide Hydrochloride

Dosage form
SOLUTION
Labeler
Kesin Pharma Corporation
Label updated
2026-06-30
Retrieved
2026-09-07
Active ingredients
LOPERAMIDE HYDROCHLORIDE
View original label and images on DailyMed ↗
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