anti diarrheal

Manufacturer
Publix Super Markets Inc
Effective date
2025-12-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:53

Label at a glance#

Productanti diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure8 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 subseq...

Storage and handling

• store at 68°-77°F (20°-25°C) • see end panel for lot number and expiration date

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

  1. fever
  2. mucus in the stool
  3. a history of liver disease
  4. 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 (1-800-222-1222).

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 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 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 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Other information

STORAGE AND HANDLING SECTION

  1. store at 68°-77°F (20°-25°C)
  2. see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg

antidiarrheal

ACTUAL SIZE

Controls the symptoms of diarrhea

Anti-diarrheal

12 CAPLETS*

*CAPSULE-SHAPED TABLETS

Compare to Imodium® A-D active ingredient

SEE NEW WARNINGS

224-63-antidiarrheal.jpg
224-63-antidiarrheal.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN5
978010loperamide hydrochloride 2 MG Oral TabletSCD5

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
56062-224-53anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
56062-224-53anti diarrheal12 in 1 CARTONTABLET, FILM COATED125
56062-224-62anti diarrheal24 in 1 CARTONTABLET, FILM COATED245
56062-224-62anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED15
56062-224-80anti diarrheal1 in 1 CARTONTABLET, FILM COATED15
56062-224-80anti diarrheal96 in 1 BOTTLETABLET, FILM COATED965

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-224-53EA - Each56062-224f2e51fbb-0c64-4e67-86ce-3b4670c321ad12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C1
LOPERAMIDEACTIVE MOIETY6X9OC3H4II1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMK1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1

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
56062-22456062-224-53, 56062-224-62, 56062-224-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET, FILM COATED / ORAL2906 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET, FILM COATED / ORAL2906 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET, FILM COATED / ORAL2906 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS LACTOSEANHYDROUS LACTOSE3SY5LH9PMKTABLET, FILM COATED / ORAL2906 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
A075232-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06

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 22:38:342026-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0684e616aacf4f…
2026-08-18 06:07:402026-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f01610625f2…
2019-09-15 20:21 UTC2019-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06f41ea6bd6efb…

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 HYDROCHLORIDEPublix Super Markets Inc44773392-eac8-48b3-ae46-b27f5fe55d8d2025-12-28WarningsExact identifier
ndc (package): 56062-224-62
ndc (package): 56062-224-80
ndc (package): 56062-224-53
ndc (product): 56062-224
ndc11 (package): 56062022462
ndc11 (package): 56062022480
ndc11 (package): 56062022453
spl id: e3cd4900-a946-4e8c-9435-7206176618fb
spl set id: 44773392-eac8-48b3-ae46-b27f5fe55d8d

Reported adverse events (FAERS/openFDA)#

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