Anti-Diarrheal

Manufacturer: Allegiant Health
Effective date: 2017-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:42:28

Label at a glance#

ProductAnti-Diarrheal

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure9 sections

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose below. 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 hours children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; ½ caplet after each subsequent lo...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-952-0050

Label contents#

Full prescribing information#

Active Ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

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 reactions 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics

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

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
find right dose below. 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 hours
children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34 to 47 lbs): ask a doctor
children under 2 years (up to 33 lbs): do not use

Other information

SPL UNCLASSIFIED SECTION

■ store at 20º-25ºC (68º-77º F) ■ avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti Diarrheal Health A2Z®

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

Anti-Diarrheal

Loperamide HCl 2mg

Controls the symptoms of diarrhea

(pill image)

12 CAPLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	5
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	5

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	Strength	SPL version
69168-248-86	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET, COATED	6		5
69168-248-86	Anti-Diarrheal	2 in 1 CARTON	TABLET, COATED	2		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-248	ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET, COATED [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 2 package rows	20210923_aca3742c-2a82-4e91-8aaf-2fce08487e56.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Anti-Diarrheal
Loperamide HCl
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69168-248	69168-248-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

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
A076497-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2003-06-10

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	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`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 HCL	Allegiant Health	aca3742c-2a82-4e91-8aaf-2fce08487e56	2017-11-13	Warnings	Exact identifier ndc (package): 69168-248-86 ndc (product): 69168-248 ndc11 (package): 69168024886 spl id: ef9b20dc-0119-49c1-bc31-2c9fc1f4d772 spl set id: aca3742c-2a82-4e91-8aaf-2fce08487e56

Reported adverse events (FAERS/openFDA)#

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