Anti-Diarrheal

Manufacturer: Geri-Care Pharmaceutical Corp
Effective date: 2025-06-11
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:28:35

Label at a glance#

ProductAnti-Diarrheal

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure8 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. 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; 1/2 caplet after each subsequent...

Storage and handling

each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 20⁰C-25⁰C (68⁰F-77⁰F) see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-540-3765

Label contents#

Full prescribing information#

Active ingredient(in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCI 2 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 HCI

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

a fever
mucus present in your 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

diarrhea lasts for more than 2 days
symptoms get worse
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.

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 right away.

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 hours
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 years (up to 33 lbs)	do not use

Other Information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 15 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 20⁰C-25⁰C (68⁰F-77⁰F)
see end flap for expiration date and lot number

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,
FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	7
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	7

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
57896-381-13	Anti-Diarrheal	2 in 1 CARTON	TABLET	2	7
57896-381-13	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET	6	7
57896-381-25	Anti-Diarrheal	6 in 1 BLISTER PACK	TABLET	6	7
57896-381-25	Anti-Diarrheal	4 in 1 CARTON	TABLET	4	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-381-12	EA - Each	57896-381	b8e1e77a-a057-4cdc-aabe-0c08ef7a3a35	1	2018-04-19
57896-381-13	EA - Each	57896-381	6de128ee-ca49-40ab-bf6f-0099f7afc3ea	1	2022-03-09
57896-381-24	EA - Each	57896-381	564ffe4d-6390-4563-b3ab-22b82d71dbdf	1	2013-06-04
57896-381-25	EA - Each	57896-381	caeb2e78-e036-4961-bb90-c907fd5ef8d0	1	2022-03-09
57896-381-96	EA - Each	57896-381	25449e42-7e92-49f5-b5db-ac40c01a3898	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57896-381	57896-381-25, 57896-381-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STARCH, CORN	O8232NY3SJ	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

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	Geri-Care Pharmaceutical Corp	0ecca2cd-c971-47b2-a2ac-ae7842dd4264	2025-06-11	Warnings	Exact identifier ndc (package): 57896-381-25 ndc (package): 57896-381-13 ndc (product): 57896-381 ndc11 (package): 57896038125 ndc11 (package): 57896038113 spl id: 37510ed6-1ec9-14e2-e063-6394a90a2609 spl set id: 0ecca2cd-c971-47b2-a2ac-ae7842dd4264

Reported adverse events (FAERS/openFDA)#

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