Loperamide Hydrochloride Capsules USP, 2 mg, liquid filled

Manufacturer
Strides Pharma, Inc. | Onesource Softgels Pte. Ltd. | Strides Pharma Science Limited
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-18 02:01:51

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

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 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 ingredients

INACTIVE INGREDIENT SECTION

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

go to www.strides.comor call Strides Pharma, Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825

Distributed by:

Strides Pharma, Inc.

Bridgewater, NJ 08807

Issued: 07/2026

†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

NDC 59556-959-06
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

2mg-12s-carton2mg-12s-carton

NDC 59556-959-05
Loperamide Hydrochloride Capsules USP, 2 mg
Anti-Diarrheal
Suitable for adults and children 12 years and over
24 Softgels*
*each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

2mg-24s-carton.jpg2mg-24s-carton.jpg

2mg-foil.jpg2mg-foil.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00359556959035GTIN-14: 00359556959035
GTIN-12: 359556959035
UPC-A: 359556959035
EAN-13: 0359556959035
GTIN storage (14 digits): 00359556959035
2mg-foil.jpg

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
59556-95959556-959-03, 59556-959-06, 59556-959-05

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52021-10-22legacy-cache2026-08-01 22:30:53

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
A213070-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11

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 22:38:342026-08A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213070-001LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORAL2021-08-11a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213070-001CGT2022-04-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213070-001CGT2022-04-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213070-001CGT2022-04-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213070-001CGT2022-04-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213070-001CGT2022-04-20782e0a99824c…
2023-01-26 05:58 UTC2023-01A213070-001CGT2022-04-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213070-001CGT2022-04-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213070-001CGT2022-04-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213070-001CGT2022-04-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213070-001CGT2022-04-20cb3db0bc1861…

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 HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsExact identifier
ndc (package): 59556-959-03
ndc (package): 59556-959-05
ndc (package): 59556-959-06
ndc (product): 59556-959
ndc11 (package): 59556095906
ndc11 (package): 59556095903
ndc11 (package): 59556095905
spl id: 58ee3114-2863-e1e7-e063-6294a90a87c2
spl set id: 4178b3cc-e1ca-4912-8b1f-eac0110a3940

Reported adverse events (FAERS/openFDA)#

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