Perrigo Anti-Diarrheal/Anti-Gas Drug Facts

Manufacturer
L. Perrigo Company
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:58:02

Label at a glance#

Productgood sense anti diarrheal anti gas
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure9 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 ...

Storage and handling

• each caplet contains: calcium 165 mg, sodium 3 mg • store between 20 ° -25 ° C (68 ° -77 ° F). Protect from light. • do not use if printed blister unit is broken or torn

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Simethicone 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 9-11 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

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 165 mg, sodium 3 mg
  • store between 20°-25°C (68°-77°F). Protect from light.
  • do not use if printed blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE®

Multi-Symptom Relief Caplet

Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg

Anti-Diarrheal/Anti-Gas

Actual Size

Relieves symptoms of diarrhea plus

• Cramps & Pressure • Bloating • Gas

Compare to active ingredients of Imodium® Multi-Symptom Relief

100% SATISFACTION GUARANTEED

24 Caplets*

*Capsule-Shaped Tablets

goodsense-anti-diarrheal-anti-gas-carton-image.jpg
goodsense-anti-diarrheal-anti-gas-carton-image.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN5
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD5

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
0113-0087-53good sense anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
0113-0087-53good sense anti diarrheal anti gas12 in 1 CARTONTABLET125
0113-0087-62good sense anti diarrheal anti gas24 in 1 CARTONTABLET245
0113-0087-62good sense anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
0113-0087-65good sense anti diarrheal anti gas30 in 1 BOTTLETABLET305
0113-0087-65good sense anti diarrheal anti gas1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0087-53EA - Each0113-0087c4c0edab-92a0-4ad8-b865-742611bf77ee12021-07-15
0113-0087-65EA - Each0113-0087d88b3db6-254a-4c4e-bf46-672b79422aba12021-07-15

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-00870113-0087-53, 0113-0087-65, 0113-0087-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05

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 22:38:342026-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05f41ea6bd6efb…

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
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
ndc (package): 0113-0087-62
ndc (package): 0113-0087-65
ndc (package): 0113-0087-53
ndc (product): 0113-0087
ndc11 (package): 00113008753
ndc11 (package): 00113008765
ndc11 (package): 00113008762
spl id: 7fbd19ec-7b82-4f11-95f0-28801a9c64b4
spl set id: 2cda08a8-3f5e-430c-84a3-d29b97d647af

Reported adverse events (FAERS/openFDA)#

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