FDA.reportPublic FDA data

Loperamide Hydrochloride - Preferred Pharmaceuticals Inc.

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-06-03 18:03:28

Label at a glance#

ProductLoperamide Hydrochloride
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure16 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9 to 11 years (60 to 95 lbs) 1 tablet after the first loose stool; 1/2 tablet after ...

Storage and handling

• store at 20° to 25°C (68° to 77°F). • do not use if carton or blister unit is open or torn • Meets USP dissolution test 2 • See side panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Loperamide hydrochloride 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 hydrochloride

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 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours

children 9 to 11 years (60 to 95 lbs)

1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours

children 6 to 8 years (48 to 59 lbs)

1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours

children 2 to 5 years (34 to 47 lbs)

ask a doctor

children under 2 years (up to 33 lbs)

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F).
  • do not use if carton or blister unit is open or torn
  • Meets USP dissolution test 2
  • See side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code .: TS/DRUGS/22/2009

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8393
*Compare to the active
ingredient of Imodium® A-D

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

Loperamide HCL Tablets USP 2mgLoperamide HCL Tablets USP 2mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN5
978010loperamide hydrochloride 2 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1285665B173BB9-3CCA-44CE-9BCB-B9ECC93D3DCF-00.jpg
Data codeData Matrix**072225*5B173BB9-3CCA-44CE-9BCB-B9ECC93D3DCF-00.jpg

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8393-2EA - Each68788-839375852d5f-2064-4d8e-8cdc-08fedb3dc98a12023-06-06
58602-701-76EA - Each58602-7013fe5611c-0ec0-4130-8a49-808f280033da12021-08-05

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-839368788-8393-2
58602-701

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
NameUNIIKind
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-07-23full-release2026-06-01 01:08:27

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
A206548-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15

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 22:38:342026-08A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1584e616aacf4f…
2026-08-18 06:07:402026-07A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206548-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2015-12-15f41ea6bd6efb…

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 HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsExact identifier
ndc (package): 68788-8393-2
ndc (product): 68788-8393
ndc11 (package): 68788839302
spl id: 4e0998b5-f4d3-4f1d-9244-07f3c78308c6
spl set id: 5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLCf3ea8779-252e-4038-ae41-500e15c548252025-01-22WarningsExact identifier
ndc (product): 58602-701

Reported adverse events (FAERS/openFDA)#

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