Loperamide Hydrochloride

Manufacturer
Physicians Total Care, Inc.
Effective date
2012-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:33

Label at a glance#

ProductLoperamide Hydrochloride
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 sections

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; ½ caplet after each subsequent l...

Storage and handling

store between 20° – 25° C (68° – 77° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl USP, 2 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-diarrheal

USE(S)

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

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

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

  • 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,

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
  • 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;
½ 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;
½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years
(up to 47 lbs)
ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store between 20° – 25° C (68° – 77° F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS?

OTC - QUESTIONS SECTION

call 1800-406-7984

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-6312-0

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS†

Each caplet(†capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

Controls The Symptoms of Diarrhea

*Compare to the active ingredient of Imodium® A-D

This is the 12 count blister carton label for Loperamide hydrochloride tablets.
This is the 12 count blister carton label for Loperamide hydrochloride tablets.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-6312-02019-09-24C16284748780-19350213a-475a-c013-e053-90daa90a1393Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-6312-0Loperamide Hydrochloride12 in 1 BLISTER PACKTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-6312LOPERAMIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]11 package rows20120427_812d636c-82d5-4eef-b154-cdf065943122.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-123-12EA - Each51660-123b916161a-9959-414f-96eb-fcc0281f28fa12013-07-02
51660-123-24EA - Each51660-12379d0070a-237a-4bd7-a5fa-d9355aef949a12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C1
LOPERAMIDEACTIVE MOIETY6X9OC3H4II1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9M1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ1
TRISTEARININACTIVE INGREDIENTP6OCJ2551R1

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
54868-631254868-6312-0
51660-123

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET / ORAL6795 mgExact identifier — unii+route+dosage form
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route+dosage form
TRISTEARINGLYCERYL TRISTEARATEP6OCJ2551RTABLET, CHEWABLE / ORAL2.3 mgExact identifier — unii+route
2 equally ranked IID candidates
TRISTEARINGLYCERYL TRISTEARATEP6OCJ2551RCAPSULE / ORAL225 mgExact identifier — unii+route
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
POWDERED CELLULOSEPOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii+route+dosage form

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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074091-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10c2088c7a36db…
2026-09-14 22:38:342026-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEOhm Laboratories Inc.c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c62024-01-11WarningsExact identifier
ndc (product): 51660-123
d30f22f1-8c60-4072-bcdb-ac5d41edb796812d636c-82d5-4eef-b154-cdf0659431222012-04-26WarningsExact identifier
spl id: d30f22f1-8c60-4072-bcdb-ac5d41edb796
spl set id: 812d636c-82d5-4eef-b154-cdf065943122

Reported adverse events (FAERS/openFDA)#

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