Anti Diarrheal

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC | LNK International, Inc.
Effective date
2025-02-03
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:54:18

Label at a glance#

ProductAnti Diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 sections

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. 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 each subsequent...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

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.
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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a 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.

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.
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 years (up to 33 lbs)do not use

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC®
Quality
Choice

NDC 63868-559-12

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

Anti-Diarrheal
Loperamide HCl Tablets, 2 mg
Anti-Diarrheal

Controls the Symptoms of Diarrhea

actual
size

12 Caplets

TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark IMODIUM® A-D.

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

1. To open, tear           2. Use ✄ to cut
at perforations and     through plastic
remove a section.       for caplet.

50844    REV0619B37502

Quality Choice 44-375
Quality Choice 44-375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN14
978010loperamide hydrochloride 2 MG Oral TabletSCD14

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
63868-559-12Anti Diarrheal6 in 1 BLISTER PACKTABLET614
63868-559-12Anti Diarrheal2 in 1 CARTONTABLET214
63868-559-24Anti Diarrheal4 in 1 CARTONTABLET414
63868-559-24Anti Diarrheal6 in 1 BLISTER PACKTABLET614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-559ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]14Current NDC, Legacy NDC, 4 package rows20250205_3d2d211f-546b-48fe-b47c-d4a254f952a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-559-12EA - Each63868-559d2b312bf-32c1-4693-8a8c-9e9781d3707e12022-07-06
63868-559-24EA - Each63868-559df89e2c3-8303-4f9c-a9b6-6e47f151f9bb12022-10-06

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
63868-55963868-559-12, 63868-559-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
A076497-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10

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 22:38:342026-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1084e616aacf4f…
2026-08-18 06:07:402026-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076497-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10f41ea6bd6efb…

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 DiarrhealLOPERAMIDE HCLCHAIN DRUG MARKETING ASSOCIATION INC3d2d211f-546b-48fe-b47c-d4a254f952a32025-02-03WarningsExact identifier
ndc (package): 63868-559-12
ndc (package): 63868-559-24
ndc (product): 63868-559
ndc11 (package): 63868055924
ndc11 (package): 63868055912
spl id: dad3f943-df76-4d9d-8485-495fe14d5a17
spl set id: 3d2d211f-546b-48fe-b47c-d4a254f952a3

Reported adverse events (FAERS/openFDA)#

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