Anti-diarrheal

Manufacturer
BI-MART | LNK International, Inc.
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:25

Label at a glance#

ProductAnti-diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

drink plenty of clear liquids 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 subsequen...

Storage and handling

do not use if seal around caplet is broken or damaged store between 20º and 25ºC (68º and 77ºF)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

Controls 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.
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
  • 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 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

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 liquids 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 over2 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

  • do not use if seal around caplet is broken or damaged
  • store between 20º and 25ºC (68º and 77ºF)

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 toll-free 1-844-912-4012 

Principal Display Panel-12 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-131-12

Compare to active ingredient in Imodium ®A-D †

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

12 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.

Distributed by BI-MART, Eugene, OR 97402

1212

Principal Display Panel-24 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-131-24

Compare to active ingredient in Imodium ®A-D †

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

24 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.

Distributed by BI-MART, Eugene, OR 97402

2424

Principal Display Panel-100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37835-131-01

Compare to active ingredient in Imodium ®A-D †

ANTI-DIARRHEAL

CAPLETS*

Loperamide HCl Tablets, 2 mg

ANTI-DIARRHEAL

Controls the symptoms of diarrhea

Original Prescription Strength

100 Caplets*

Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)

†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.

Distributed by BI-MART, Eugene, OR 97402

100100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN1
978010loperamide hydrochloride 2 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-131-01Anti-diarrheal100 in 1 BOTTLETABLET1001
37835-131-12Anti-diarrheal6 in 1 BLISTER PACKTABLET61
37835-131-12Anti-diarrheal2 in 1 CARTONTABLET21
37835-131-24Anti-diarrheal4 in 1 CARTONTABLET41
37835-131-24Anti-diarrheal6 in 1 BLISTER PACKTABLET61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-131ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [BI-MART]15 package rows20250523_a3687b81-1f4d-49d5-a25f-b16560ab83d8.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-13137835-131-12, 37835-131-24, 37835-131-01

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
358df35b-9290-7e92-e063-6394a90a6b07a3687b81-1f4d-49d5-a25f-b16560ab83d82025-05-01WarningsExact identifier
spl id: 358df35b-9290-7e92-e063-6394a90a6b07
spl set id: a3687b81-1f4d-49d5-a25f-b16560ab83d8

Reported adverse events (FAERS/openFDA)#

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