FDA.reportPublic FDA data

Loperamide Hydrochloride

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2025-01-22
Label type
Human OTC Drug Label
Version
10
Source
full-release
Hydrated at
2026-06-01 00:53:25

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 each...

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-701-76

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

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN10
978010loperamide hydrochloride 2 MG Oral TabletSCD10

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
58602-701-01Loperamide Hydrochloride1 in 1 CARTONTABLET110
58602-701-01Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-02Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-02Loperamide Hydrochloride2 in 1 CARTONTABLET210
58602-701-76Loperamide Hydrochloride6 in 1 BLISTER PACKTABLET610
58602-701-76Loperamide Hydrochloride4 in 1 CARTONTABLET410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-701LOPERAMIDE HYDROCHLORIDE TABLET [AUROHEALTH LLC]10Current NDC, Legacy NDC, 6 package rows20250123_f3ea8779-252e-4038-ae41-500e15c54825.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
58602-70158602-701-01, 58602-701-02, 58602-701-76

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLCf3ea8779-252e-4038-ae41-500e15c548252025-01-22WarningsExact identifier
ndc (package): 58602-701-01
ndc (package): 58602-701-02
ndc (package): 58602-701-76
ndc (product): 58602-701
ndc11 (package): 58602070101
ndc11 (package): 58602070102
ndc11 (package): 58602070176
spl id: 1645400c-43fb-4b64-98bc-33f85ce827f7
spl set id: f3ea8779-252e-4038-ae41-500e15c54825

Reported adverse events (FAERS/openFDA)#

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