FDA.reportPublic FDA data

Equate Anti Diarrheal Anti Gas Multi-Symptom Relief

Manufacturer
WALMART INC.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:27

Label at a glance#

ProductEquate Anti Diarrheal Anti Gas Multi-Symptom Relief
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure17 sections

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...

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Anti-gas

Use(s)

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 over2 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; ½ 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; ½ 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 (up to 33 lbs)do not use

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 180 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light
  • do not use if blister unit is torn or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

SPL UNCLASSIFIED SECTION

DISTRIBURED BY: Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

**This product is not manufactured or distributed by Johnson and Johnson Consumer Inc. • McNeil Consumer Healthcare, owner of the registered trademark Imodium ® Multi-Symptom Relief.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79903-302-12

equate™

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Multi-Symptom Relief Caplet

Relieves symptoms of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

12 Caplets*

*capsule-shaped tablets

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN2
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD2

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
79903-302-12Equate Anti Diarrheal Anti Gas Multi-Symptom Relief12 in 1 BLISTER PACKTABLET122
79903-302-12Equate Anti Diarrheal Anti Gas Multi-Symptom Relief1 in 1 CARTONTABLET12
79903-302-24Equate Anti Diarrheal Anti Gas Multi-Symptom Relief12 in 1 BLISTER PACKTABLET122
79903-302-24Equate Anti Diarrheal Anti Gas Multi-Symptom Relief2 in 1 CARTONTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-302EQUATE ANTI DIARRHEAL ANTI GAS MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [WALMART INC.]2Current NDC, 4 package rows20250124_23af573f-8d40-6b82-e063-6394a90aabab.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-30279903-302-12, 79903-302-24

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
ACESULFAME POTASSIUM23OV73Q5G9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB
DIMETHICONE92RU3N3Y1OACTIB

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
A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27

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 22:38:342026-08A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-2784e616aacf4f…
2026-08-18 06:07:402026-07A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-274b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214541-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2021-05-27a50c72e98297…

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
Equate Anti Diarrheal Anti Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWALMART INC.23af573f-8d40-6b82-e063-6394a90aabab2025-01-01WarningsExact identifier
ndc (package): 79903-302-12
ndc (package): 79903-302-24
ndc (product): 79903-302
ndc11 (package): 79903030212
ndc11 (package): 79903030224
spl id: 2b4e13d7-40b0-1543-e063-6294a90a677b
spl set id: 23af573f-8d40-6b82-e063-6394a90aabab

Reported adverse events (FAERS/openFDA)#

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