LOPERAMIDE HYDROCHLORIDE solution

Drug Labeling and Warnings

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

NDC: 81033-067-35

Loperamide Hydrochloride Oral Solution, USP

2 mg per 15 mL

Delivers 15 mL

20 x 15 mL Unit Dose Cups

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-067(NDC:69452-405)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	1 mg  in 7.5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARAMEL (UNII: T9D99G2B1R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	green (light green opaque)	Score
Shape		Size
Flavor	MINT (flavadew coolmint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-067-34	30 in 1 CARTON	06/30/2026
1	NDC: 81033-067-07	7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-067-35	30 in 1 CARTON	06/30/2026
2	NDC: 81033-067-15	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA220100	11/13/2024

Labeler - Kesin Pharma Corporation (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		117447816	label(81033-067) , pack(81033-067) , repack(81033-067)