Loperamide Hydrochloride - Kesin Pharma Corporation

Manufacturer: Kesin Pharma Corporation
Effective date: 2026-06-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: daily-update
Hydrated at: 2026-06-03 18:03:34

Label at a glance#

ProductLoperamide Hydrochloride

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure11 sections

Indications and uses

Controls symptoms of diarrhea, including Travelers' Diarrhea

Dosage and administration

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 st...

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-616-218-2725

Label contents#

Full prescribing information#

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl, USP 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-Diarrheal

Uses

INDICATIONS & USAGE SECTION

Controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-616-218-2725

*This product is not manufactured or distributed by the owners of Imodium ®A-D.

SPL UNCLASSIFIED SECTION

Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-067-V01
Rev. 05/2026

Kesin Pharma Logo

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

Loperamide OS 7.5 mL Carton

PACKAGE LABEL.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

Loperamide OS 15 mL Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LOPERAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Source image
Data code	Code 128	01003810330673461700000010K0000000	Loperamide_OS_7.5mL_Carton_30ct.jpg
Data code	Code 128	01003810330673531700000010K0000000	Loperamide_OS_15mL_Carton_30ct.jpg
Data code	Code 128	K0000000	Loperamide_OS_7.5mL_Carton_30ct.jpg, Loperamide_OS_15mL_Carton_30ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Loperamide Hydrochloride
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GLYCERIN
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CARAMEL
PROPYLENE GLYCOL
WATER
DIMETHICONE
SODIUM BENZOATE
SUCRALOSE
TITANIUM DIOXIDE
XANTHAN GUM
LOPERAMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81033-067	81033-067-07, 81033-067-34, 81033-067-15, 81033-067-35
69452-405

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GLYCERIN	PDC6A3C0OX	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
CARAMEL	T9D99G2B1R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A220100-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL			2025-09-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A220100-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2025-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220100-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2025-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A220100-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A220100-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220100-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2025-09-19	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Kesin Pharma Corporation	52e6ecc5-5f3d-9989-e063-6294a90af2dc	2026-06-30	Warnings	Exact identifier ndc (package): 81033-067-35 ndc (package): 81033-067-15 ndc (package): 81033-067-07 ndc (package): 81033-067-34 ndc (product): 81033-067 ndc11 (package): 81033006735 ndc11 (package): 81033006707 ndc11 (package): 81033006734 ndc11 (package): 81033006715 spl id: 52e6ecd3-7e31-a74b-e063-6294a90ab15c spl set id: 52e6ecc5-5f3d-9989-e063-6294a90af2dc
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE ORAL	Bionpharma Inc.	4bd0939e-c172-d962-e063-6394a90a44b5	2026-02-27	Warnings	Exact identifier ndc (product): 69452-405

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.