Handy Solutions Anti-Diarrheal

Manufacturer: Navajo Manufacturing Company Inc.
Effective date: 2023-03-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:54:29

Label at a glance#

ProductHandy Solutions Anti-Diarrheal

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure8 sections

Indications and uses

Controls the symptoms of diarrhea, including Traveler’s diarrhea

Dosage and administration

do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children (12 years and older): Take 2 caplets after the first loose bowel movement followed by 1 caplet after each subsequent loose bowel movement but no more than 4 caplets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Contacts and useful links#

PhoneLabel contact1-800-525-5097

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide Hydrochloride 2 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Controls the symptoms of diarrhea, including Traveler’s diarrhea

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

• if you have bloody or black stools

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• a fever
• mucus in 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 more than 2 days
• you get abdominal swelling or bulging. These may be signs of a serious condition.

If you are pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more than directed
drink plenty of clear fluids to help prevent dehydration caused by diarrhea


Adults and children (12 years and older):	Take 2 caplets after the first loose bowel movement followed by 1 caplet after each subsequent loose bowel movement but no more than 4 caplets in 24 hours.
Children under 12 years:	Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

• store between 68º - 77ºF (20º - 25ºC)
• tamper-evident sealed packets
• do not use any opened or torn packet

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow # 10, FD&C blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-525-5097

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HS Anti-Diarrheal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	3
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67751-162-01	2023-03-15	C162847	48780-1	f386c64a-201c-0266-e053-dadaa90a7c1a	Handy Solutions Anti-Diarrheal
67751-162-01	2023-01-30	C162847	48780-1	f386c64a-201c-0266-e053-dadaa90a7c1a	Handy Solutions Anti-Diarrheal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67751-162-01	Handy Solutions Anti-Diarrheal	1 in 1 POUCH	TABLET	1		3
67751-162-01	Handy Solutions Anti-Diarrheal	1 in 1 CARTON	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-162	HANDY SOLUTIONS ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230316_76e32e66-4af5-47a5-83ff-cbba206975d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47682-200-33	EA - Each	47682-200	f07bc0d3-2ced-4052-ba14-126376ba97df	1	2012-07-24
47682-200-50	EA - Each	47682-200	1792fba4-32e7-461b-9844-385042675db5	1	2012-07-24
47682-200-64	EA - Each	47682-200	94aca123-bb93-43e6-bf00-3c3df07db82a	1	2023-08-08
47682-200-69	EA - Each	47682-200	80247ac0-4431-4ac1-893d-7b7a9a0347e9	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Handy Solutions Anti-Diarrheal
LOPERAMIDE HYDROCHLORIDE
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
POWDERED CELLULOSE
LOPERAMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67751-162	67751-162-01
47682-200

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
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CROSPOVIDONE	2S7830E561	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POWDERED CELLULOSE	SMD1X3XO9M	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Exact identifier ndc (product): 47682-200
Handy Solutions Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76e32e66-4af5-47a5-83ff-cbba206975d6	2023-03-15	Warnings	Exact identifier ndc (package): 67751-162-01 ndc (product): 67751-162 ndc11 (package): 67751016201 spl id: f6f79fd3-55a5-4d2a-e053-6394a90a4ddd spl set id: 76e32e66-4af5-47a5-83ff-cbba206975d6

Reported adverse events (FAERS/openFDA)#

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