FDA.reportPublic FDA data

LOPERAMIDE HYDROCHLORIDE - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-08-28
Label type
Human OTC Drug Label
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:01:10

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. not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

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
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Other information

SPL UNCLASSIFIED SECTION

  • store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light.
  • do not use if carton or blister unit is open or torn
  • avoid excessive heat above 40°C (104°F)
  • see side panel for lot number and expiration date
  • FDA approved dissolution test specifications differ from USP.

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-855-274-4122 


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


Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg (24 Softgels) Blister Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-727-78

†Compare to the active ingredient
in Imodium® A-D

Loperamide Hydrochloride
Capsules USP, 2 mg
(Soft Gelatin Capsules)
Anti-Diarrheal

Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over

Actual Size

24 Softgels*
*each liquid-filled capsule contains
2 mg Loperamide Hydrochloride, USP

Figure1Figure1

DailyMed Product Concepts#

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

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
58602-72758602-727-74, 58602-727-75, 58602-727-80, 58602-727-76, 58602-727-78, 58602-727-77

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
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
GELATIN TYPE B BOVINE (160 BLOOM)1T8387508XIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-05full-release2026-06-01 01:31:35

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
A220372-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220372-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2025-12-29a50c72e98297…

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 LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsExact identifier
ndc (package): 58602-727-75
ndc (package): 58602-727-74
ndc (package): 58602-727-76
ndc (package): 58602-727-77
ndc (package): 58602-727-78
ndc (package): 58602-727-80
ndc (product): 58602-727
ndc11 (package): 58602072780
ndc11 (package): 58602072774
ndc11 (package): 58602072777
ndc11 (package): 58602072775
ndc11 (package): 58602072776
ndc11 (package): 58602072778
spl id: fe72649e-b4ec-4aaa-9a99-b81104a37710
spl set id: f9a53a23-a8ea-4521-8f0b-1bc2a658ff68

Reported adverse events (FAERS/openFDA)#

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