Loperamide Hydrochloride

Manufacturer
RITE AID CORPORATION | Strides Pharma Global Pte. Ltd. | Strides Pharma Science Limited
Effective date
2022-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:26

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 HCl

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 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.

OTC - WHEN USING SECTION

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor

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.

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

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F). Protect from Light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

Inactive ingredients butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water, printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.                         

Questions or comments?

OTC - QUESTIONS SECTION

Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST.

Manufactured by:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Rite Aid

30 Hunter Lane, Camp Hill,

PA 17011.

Revised: 06/2022

†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium® A-D

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D

NDC 11822-959-06

Loperamide Hydrochloride Capsules USP, 2 mg

Anti-Diarrheal

Suitable for adults and children 12 years and over

12 Softgels*

*each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

Carton Label
Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978006loperamide HCl 2 MG Oral CapsulePSN1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1

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
11822-9590-52025-01-30C16284748780-12cef2736-869b-d83d-e063-dadaa90ab31fDrug Facts
11822-9590-62025-01-30C16284748780-12cef2736-869b-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-9590-3Loperamide Hydrochloride12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
11822-9590-5Loperamide Hydrochloride2 in 1 CARTONCAPSULE, LIQUID FILLED21
11822-9590-6Loperamide Hydrochloride12 in 1 CARTONCAPSULE, LIQUID FILLED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-9590LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [RITE AID CORPORATION]13 package rows20240630_462db53c-e286-425b-a9d9-0c39eef84d04.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-959011822-9590-3, 11822-9590-5, 11822-9590-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
904a0931-c5a2-4b6f-a65d-cd8b53cdf658462db53c-e286-425b-a9d9-0c39eef84d042022-06-09WarningsExact identifier
spl id: 904a0931-c5a2-4b6f-a65d-cd8b53cdf658
spl set id: 462db53c-e286-425b-a9d9-0c39eef84d04

Reported adverse events (FAERS/openFDA)#

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