WELMATE Anti Diarrheal Loperamide HCl Softgels

Manufacturer: YYBA CORP
Effective date: 2022-11-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:51:18

Label at a glance#

ProductWELMATE Anti Diarrheal Loperamide HCl Softgels

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure8 sections

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-935-6737

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

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 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
in children under 12 years of age

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 before use if you are 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 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
not for use in children under 12 years of age
adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

SPL UNCLASSIFIED SECTION

do not use if blister unit is torn or open
store at 20°- 25°C (68° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
978006	loperamide HCl 2 MG Oral Capsule	PSN	3
978006	loperamide hydrochloride 2 MG Oral Capsule	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73581-102-24	WELMATE Anti Diarrheal Loperamide HCl Softgels	12 in 1 BLISTER PACK	CAPSULE	12		3
73581-102-24	WELMATE Anti Diarrheal Loperamide HCl Softgels	2 in 1 CARTON	CAPSULE	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73581-102	WELMATE ANTI DIARRHEAL LOPERAMIDE HCL SOFTGELS (LOPERAMIDE HYDROCHLORIDE) CAPSULE [YYBA CORP]	3	Current NDC, Legacy NDC, 2 package rows	20221102_ae2e15e9-1707-296d-e053-2995a90a1b95.zip

Products#

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

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

WELMATE Anti Diarrheal Loperamide HCl Softgels
LOPERAMIDE HYDROCHLORIDE
BUTYLATED HYDROXYANISOLE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
GLYCERYL CAPRYLATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
WATER
LOPERAMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73581-102	73581-102-24

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
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL CAPRYLATE	TM2TZD4G4A	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
WATER	059QF0KO0R	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021855-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL		RLD	2005-08-04
N021855-002	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL		RLD, RS	2005-08-04

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`74a2ff9319b5…`

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
WELMATE Anti Diarrheal Loperamide HCl Softgels	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e15e9-1707-296d-e053-2995a90a1b95	2022-11-01	Warnings	Exact identifier ndc (package): 73581-102-24 ndc (product): 73581-102 ndc11 (package): 73581010224 spl id: ec6b87f1-e600-21c2-e053-2a95a90ab76d spl set id: ae2e15e9-1707-296d-e053-2995a90a1b95

Reported adverse events (FAERS/openFDA)#

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