FDA.reportPublic FDA data

Loperamide HCl and Simethicone

Manufacturer
Ohm Laboratories Inc. | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date
2022-08-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:36

Label at a glance#

ProductLoperamide HCl and Simethicone
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure12 sections

Indications and uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Dosage and administration

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than ...

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl USP, 2 mg

Simethicone USP, 125 mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

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
  • if you have difficulty swallowing

Ask a doctor before use if you have

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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.
  • you have difficulty swallowing the caplet

If pregnant or breast-feeding,

SPL UNCLASSIFIED 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 (1800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • take with a full (8 oz.) glass of water
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over

2 caplets after the first loose

stool; 1 caplet after each

subsequent loose stool;

but no more than 4 caplets in 24 hours

children 9-11 years (60-95 lbs)

1 caplet after the first loose

stool; 1/2 caplet after each

subsequent loose stool;

but no more than 3 caplets in 24 hours

children 6-8 years (48-59 lbs)

1 caplet after the first loose

stool; 1/2 caplet after each

subsequent loose stool;

but no more than 2 caplets in 24 hours

children 2-5 years (34 to 47 lbs)

ask a doctor

children under 2 years (upto 33 lbs)

do not use

Other information

SPL UNCLASSIFIED SECTION

  • calcium: contains 142 mg/caplet
  • store between 20-25° C (68-77° F). Protect from light.
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Manufactured by:
Sun Pharmaceutical
Industries Limited,
MOHALI, INDIA

Distributed by:
Ohm Laboratories Inc.,
New Brunswick,
NJ 08901

PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-06

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

6 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-12

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

12 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-18

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

18 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-24

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

24 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
51660-069-06Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-12Loperamide HCl and Simethicone2 in 1 CARTONTABLET23
51660-069-12Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-18Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-18Loperamide HCl and Simethicone3 in 1 CARTONTABLET33
51660-069-24Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-24Loperamide HCl and Simethicone4 in 1 CARTONTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-069LOPERAMIDE HCL AND SIMETHICONE TABLET [OHM LABORATORIES INC.]3Current NDC, Legacy NDC, 7 package rows20220908_06f99f59-e702-49f1-bb1d-e7cf58c54c30.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51660-06951660-069-06, 51660-069-12, 51660-069-18, 51660-069-24

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
DIMETHICONE92RU3N3Y1OACTIB
CALCIUM SILICATES4255P4G5MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
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
A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06

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 22:38:342026-08A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0684e616aacf4f…
2026-08-18 06:07:402026-07A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-063f01610625f2…
2019-09-15 20:21 UTC2019-09A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077500-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2006-09-06f41ea6bd6efb…

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 HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
ndc (package): 51660-069-24
ndc (package): 51660-069-12
ndc (package): 51660-069-06
ndc (package): 51660-069-18
ndc (product): 51660-069
ndc11 (package): 51660006918
ndc11 (package): 51660006924
ndc11 (package): 51660006906
ndc11 (package): 51660006912
spl id: 86ddd92a-920c-40b8-b0bd-29bfb3b38bfc
spl set id: 06f99f59-e702-49f1-bb1d-e7cf58c54c30

Reported adverse events (FAERS/openFDA)#

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