FDA.reportPublic FDA data

Anti-Diarrheal, CVP HEALTH

Manufacturer
Lil' Drug Store Products, Inc. | Ohm Laboratories Inc.
Effective date
2024-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:31

Label at a glance#

ProductAnti-Diarrheal, Caseys 4good
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Directions 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. 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 e...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Loperamide HCl, USP 2 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

​Use

Controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

​Warnings

Allergy alert

SPL UNCLASSIFIED SECTION

Allergy alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Heart alert

SPL UNCLASSIFIED SECTION

Heart alert:Taking more than directed can cause serious heart problems or death.

Do not use

OTC - DO NOT USE SECTION

Do not useif you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.
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; 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 - 47 lbs)ask a doctor
children under 2 (up to 33 lbs)do not use

Other information

SPL UNCLASSIFIED SECTION

Other information

  • store between 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?
call toll-free 1-877-507-6516(M-F 8AM - 4:30PM CST)

Anti-Diarrheal 4ct, CVP ®HEALTH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the
active ingredient in
Imodium ®A-D*

Anti-
Diarrheal

Loperamide HCl Tablets,
USP 2mg

Controls the Symptoms
of Diarrhea

[caplet image]

actual size

4 Caplets*

CVP ®

HEALTH

PDP/PackagePDP/Package

Anti-Diarrheal 4ct, Casey's 4good TM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the
active ingredient in
Imodium ®A-D*

Anti-
Diarrheal
Loperamide HCI Tablets, USP 2mg
Controls the symptoms of diarrhea

[Casey's logo]

[caplet image]

actual size

4 CAPLETS**

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN2
978010loperamide hydrochloride 2 MG Oral TabletSCD2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6359-2Anti-Diarrheal, Caseys 4good2 in 1 CARTONTABLET22
66715-6359-2Anti-Diarrheal, Caseys 4good2 in 1 POUCHTABLET22
66715-6559-2Anti-Diarrheal, CVP HEALTH2 in 1 POUCHTABLET22
66715-6559-2Anti-Diarrheal, CVP HEALTH2 in 1 CARTONTABLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6359ANTI-DIARRHEAL, CASEYS 4GOOD (LOPERAMIDE HCL) TABLET ANTI-DIARRHEAL, CVP HEALTH (LOPERAMIDE HCL) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, 2 package rows20250101_043b0ab4-8fba-37d1-e063-6394a90a4cd4.zip
66715-6559ANTI-DIARRHEAL, CASEYS 4GOOD (LOPERAMIDE HCL) TABLET ANTI-DIARRHEAL, CVP HEALTH (LOPERAMIDE HCL) TABLET [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, 2 package rows20250101_043b0ab4-8fba-37d1-e063-6394a90a4cd4.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-635966715-6359-2
66715-655966715-6559-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
STARCH, CORNO8232NY3SJIACT
POWDERED CELLULOSESMD1X3XO9MIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
POWDERED CELLULOSESMD1X3XO9MIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB

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
A074091-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10

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 22:38:342026-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10f41ea6bd6efb…

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
Anti-Diarrheal, Caseys 4goodLOPERAMIDE HCLLil' Drug Store Products, Inc.043b0ab4-8fba-37d1-e063-6394a90a4cd42024-12-29WarningsExact identifier
ndc (package): 66715-6359-2
ndc (package): 66715-6559-2
ndc (product): 66715-6559
ndc (product): 66715-6359
ndc11 (package): 66715635902
ndc11 (package): 66715655902
spl id: 2a765728-0495-0728-e063-6394a90a2a63
spl set id: 043b0ab4-8fba-37d1-e063-6394a90a4cd4

Reported adverse events (FAERS/openFDA)#

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