FDA.reportPublic FDA data

Loperamide Hydrochloride

Manufacturer
Medline Industries, LP | Ohm Laboratories Inc
Effective date
2024-12-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:49:31

Label at a glance#

ProductLoperamide Hydrochloride
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure10 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; 1/2 caplet after each subsequent...

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

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
Heart alert:Taking more than directed can cause serious heart problems or death

Do not use if

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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 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 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 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

OTHER SAFETY INFORMATION

  • store between 20° - 25° C (68° - 77° F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT IS 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 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Manufacturing Information

SPL UNCLASSIFIED SECTION

Packaged for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Packaged in USA with domestic and foreign materials
www.medline.com
1-800-MEDLINE (633-5463)
REF: OTCS0801C2
V1 RG22OHM

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

V1 RG22OHMV1 RG22OHM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN8
978010loperamide hydrochloride 2 MG Oral TabletSCD8

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
53329-664-57Loperamide Hydrochloride12 in 1 BLISTER PACKTABLET128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-664LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, LP]8Legacy NDC, 1 package rows20250101_03d68bcf-6413-4fe3-8263-39cc315452d2.zip

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
53329-66453329-664-57

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE68401960MKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
TRISTEARINP6OCJ2551RIACT
MAGNESIUM STEARATE70097M6I30IACT
POWDERED CELLULOSESMD1X3XO9MIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB

Source Document#

Source XML · Source PDF

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 · 18 matching rows.

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

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-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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074091-001LOPERAMIDE 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…
2022-10-28 04:53 UTC2022-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10f41ea6bd6efb…

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
2a761ab3-5c74-92c0-e063-6294a90a93aa03d68bcf-6413-4fe3-8263-39cc315452d22024-12-29WarningsExact identifier
spl id: 2a761ab3-5c74-92c0-e063-6294a90a93aa
spl set id: 03d68bcf-6413-4fe3-8263-39cc315452d2

Reported adverse events (FAERS/openFDA)#

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