Anti Diarrheal

Manufacturer
Rebel Distributors Corp
Effective date
2011-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:26

Label at a glance#

ProductAnti Diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 sections

Indications and uses

controls symptoms of diarrhea, including Travelers’ Diarrhea

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise use age. only use attached measuring cup to dose product adults and children 12 years and over 4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours childre...

Storage and handling

do not use if carton is opened or if printed plastic neckband is broken or missing store between 20°-25°C (68°-77°F) see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Uses

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

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics

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
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • only use attached measuring cup to dose product
adults and children 12 years and over4 teaspoonfuls (1 dosage cup) after the first loose stool; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose stool; but no more than 8 teaspoonfuls in 24 hours
children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 6 teaspoonfuls in 24 hours
children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose stool; 1 teaspoonful (1/4 dosage cup) after each subsequent loose stool; but no more than 4 teaspoonfuls in 24 hours
children under 6 years (up to 47 lbs)ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not use if carton is opened or if printed plastic neckband is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (0.5%), benzoic acid, citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide HCl 1mg
Loperamide HCl 1mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
977986loperamide HCl 1 MG in 5 mL Oral SolutionPSN1
977986loperamide hydrochloride 0.2 MG/ML Oral SolutionSCD1
977986loperamide hydrochloride 1 MG per 5 ML Oral SolutionSY1
977986loperamide hydrochloride 2 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-978-042019-09-24C16284748780-1934fe258-4ca1-48b1-e053-8cdaa90a720aRite Aid Corporation Anti-Diarrheal Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-978-04Anti Diarrheal120 mL in 1 BOTTLESOLUTION1201
21695-978-04Anti Diarrheal1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-978ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20111227_4339d964-1997-4c0e-973e-aa69b123b33d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C1
LOPERAMIDEACTIVE MOIETY6X9OC3H4II1

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
21695-97821695-978-04
0113-0377

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
A073243-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21

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 22:38:342026-08A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073243-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1992-01-21f41ea6bd6efb…

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
4339d964-1997-4c0e-973e-aa69b123b33d4339d964-1997-4c0e-973e-aa69b123b33d2011-09-13WarningsExact identifier
spl id: 4339d964-1997-4c0e-973e-aa69b123b33d
spl set id: 4339d964-1997-4c0e-973e-aa69b123b33d

Reported adverse events (FAERS/openFDA)#

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