ANTI-DIARRHEAL loperamide hcl tablet

Manufacturer: Lil' Drug Store Products, Inc. | Ohm Laboratories Inc.
Effective date: 2024-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:50:16

Label at a glance#

ProductAnti-Diarrheal

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure10 sections

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. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hour children 9 - 11 years (60 - 95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subseq...

Storage and handling

Other information ■ store between 68-77°F (20-25°C)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-351-2000

Label contents#

Full prescribing information#

Active Ingredient ( in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl, USP 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

SPL UNCLASSIFIED SECTION

Allergy alert

WARNINGS SECTION

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Heart alert

SPL UNCLASSIFIED SECTION

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

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 producttiredness, 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.

adults and children 12 years and over

2 caplets after the first loose stool;

1 caplet after each subsequent loose stool;
but no more than 4 caplets in 24 hour

children 9 - 11 years

(60 - 95 lbs)

1 caplet after the first loose stool;

1/2 caplet after each subsequent loose stool;

but no more than 3 caplets in 24 hours

children 6 - 8 years

(48 - 59 lbs)

1 caplet after the first loose stool;

1/2 caplet after each subsequent loose stool;
but no more than 2 caplets in 24 hours

children 2 - 5 years

(34 - 47 lbs)

ask a doctor

children under 2

(up to 33 lbs)

do not use

Other Information

STORAGE AND HANDLING SECTION

Other information

■ store between 68-77°F (20-25°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow
no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated
vegetable oil, magnesium stearate, powdered cellulose, pregelatinized
starch

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

2 mg Loperamide Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Imodium® A-D*

Diamode

Anti-Diarrheal Relief

Loperamide HCl

Tablets, USP 2 mg

[tablet image]

actual size

1 CAPLET IN EACH PACKET

READ DRUG FACTS AND INSTRUCTIONS ON PACKET

Anti Diarrheal Relief 1 Caplet in each pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	4
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29485-9286-2	Anti-Diarrheal	25 in 1 BOX	TABLET	25	4
29485-9286-2	Anti-Diarrheal	1 in 1 POUCH	TABLET	1	4
29485-9286-3	Anti-Diarrheal	30 in 1 BOX	TABLET	30	4
29485-9286-3	Anti-Diarrheal	1 in 1 POUCH	TABLET	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-9286	ANTI-DIARRHEAL (LOPERAMIDE HCI) TABLET [LIL' DRUG STORE PRODUCTS, INC.]	4	Current NDC, Legacy NDC, 4 package rows	20250101_eec84fa1-262f-6e77-e053-2995a90a325b.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Anti-Diarrheal
Loperamide HCI
POWDERED CELLULOSE
D&C YELLOW NO. 10
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 1
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
STARCH, CORN
ANHYDROUS LACTOSE
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
29485-9286	29485-9286-2, 29485-9286-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POWDERED CELLULOSE	SMD1X3XO9M	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	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
A074091-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			1992-12-10

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.

Product history page 1 of 2 · 43 observed 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	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HCI	Lil' Drug Store Products, Inc.	eec84fa1-262f-6e77-e053-2995a90a325b	2024-12-29	Warnings	Exact identifier ndc (package): 29485-9286-3 ndc (package): 29485-9286-2 ndc (product): 29485-9286 ndc11 (package): 29485928602 ndc11 (package): 29485928603 spl id: 2a761ab3-5c89-92c0-e063-6294a90a93aa spl set id: eec84fa1-262f-6e77-e053-2995a90a325b

Reported adverse events (FAERS/openFDA)#

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