FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Manufacturer
NORTHEAST PHARMA | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2025-01-07
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:18

Label at a glance#

ProductLoperamide Hydrochloride and Simethicone
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure16 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 4 caplet...

Storage and handling

each caplet contains: calcium 165 mg, sodium 4 mg store between 20° to 25°C (68° to 77°F). Protect from light. do not use if carton is opened or if individual blister units are torn or opened

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet) 

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: 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

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.
  • you have difficulty swallowing the caplet

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.

(1-800-222-1222)

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 to 11 years (60 to 95 lbs)
1 caplet after the first loose stool; ½ caplet
after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6 to 8 years (48 to 59 lbs)
1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets 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

  • each caplet contains: calcium 165 mg, sodium 4 mg
  • store between 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if carton is opened or if individual blister units are torn or opened

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)


Dist. By: Northeast Pharma
South Burlington, VT 05403
1-800-383-0648

Made in India

Code: AP/DRUGS/04/2016

REV 1021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heartland™

Pharna Co.

NDC 80136-384-24
LOPERAMIDE HCl and
SIMETHICONE TABLETS
2 mg/125 mg

LOPERAMIDE HCl 2 mg - ANTIDIARRHEAL / SIMETHICONE 125 mg - ANTI-GAS

Multi-Sympton Relief Caplet

Relieves symptoms of diarrhea plus

•  Cramps & Pressure     •   Bloating    •  Gas   

Compare to the active ingridients of
IMODIUM ®  MULTI-SYMPTON RELIEF **

T    79
Actual Size

24 Caplets*
*capsule-shaped tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

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
80136-384-24Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
80136-384-24Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-384LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [NORTHEAST PHARMA]3Current NDC, Legacy NDC, 2 package rows20250112_d106d8e5-cdbb-4f90-8456-e692ffe7f4e6.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
80136-38480136-384-24

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
ACESULFAME POTASSIUM23OV73Q5G9IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
STEARIC ACID4ELV7Z65APIACT

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
A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14

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 22:38:342026-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1484e616aacf4f…
2026-08-18 06:07:402026-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-145aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211059-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2020-12-14a50c72e98297…

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 Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONENORTHEAST PHARMAd106d8e5-cdbb-4f90-8456-e692ffe7f4e62025-01-07WarningsExact identifier
ndc (package): 80136-384-24
ndc (product): 80136-384
ndc11 (package): 80136038424
spl id: dc8efd7a-1632-46ea-8d21-9b443ff6081c
spl set id: d106d8e5-cdbb-4f90-8456-e692ffe7f4e6

Reported adverse events (FAERS/openFDA)#

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