Anti-Diarrheal

Manufacturer
TOP CARE (Topco Associates LLC) | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2022-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:52:49

Label at a glance#

ProductAnti-Diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure17 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 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCI 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 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 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 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours

Other information

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F). Protect from Light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

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 or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-423-0139

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by the owners of Imodium ® A-D.

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Scan here for more
information or
call 1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO BMAA0521
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com
√ QUALITY GUARANTEED

L0000460

Lot #
Expiration Date
Rev # 06/21

24's carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCareTM

health

NDC 36800-208-12

COMPARE TO

IMODIUM® A-D

ACTIVE INGREDIENT†

Anti-Diarrheal

LOPERAMIDE HCl

SOFT GELATIN CAPSULES, 2 mg

Controls the Symptoms

of Diarrhea

Suitable for Adults & Children

12 years and over

actual size

24 SOFTGELS*

*each liquid-filled capsule
contains 2 mg Loperamide HCl

24's carton24's carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978006loperamide HCl 2 MG Oral CapsulePSN2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD2

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
36800-208-12Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED22
36800-208-12Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-208ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]2Current NDC, Legacy NDC, 2 package rows20230101_c62bc8d4-0857-16fc-e053-2a95a90a0c41.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-20836800-208-12

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021855-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04
N021855-002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0484e616aacf4f…
2026-09-14 22:38:342026-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0484e616aacf4f…
2026-08-18 06:07:402026-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0474a2ff9319b5…

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
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
ndc (package): 36800-208-12
ndc (product): 36800-208
ndc11 (package): 36800020812
spl id: f10fa51b-9cb9-502a-e053-2995a90a11d1
spl set id: c62bc8d4-0857-16fc-e053-2a95a90a0c41

Reported adverse events (FAERS/openFDA)#

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