Antidiarrheal LOPERAMIDE Solution

Manufacturer
Holliday-Scott S.A. | Vasudha Pharma Chem Limited
Effective date
2013-07-31
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:39:38

Label at a glance#

ProductAntidiarrheal LOPERAMIDE
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure10 sections

Storage and handling

10 ml dropper Keep between 40 degree and 95 degree F

Label contents#

Full prescribing information#

Antidiarrheal LOPERAMIDE Solution

DESCRIPTION SECTION

Oral Way For dogs and cats  Loperamide is meperidine derivative.  The antidiarrheic action is achieved by its modulating effect on intestinal motility, which, in turn is achieved through the stimulation of the rhythmic segmentation (acting on circular smooth muscle) and by decreasing the peristalsis (with either no effect on the longitudinal smooth muscle, or relaxing it), as well as due to the antisecretory effect, increasing the absorption of nutrients, water and electrolytes, achieved by blocking the channel of calcium or by inhibiting the calcium binding protein, calmodulin

Formula:

OTC - ACTIVE INGREDIENT SECTION

Each ml of oral solution contains:
Loperamide hydrochloride...........2 mg Vehicle q.s.

Indications:

INDICATIONS & USAGE SECTION

Symptomatic treatment of acute and chronic diarrhea.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

National poison centre: 1-800-222-1222 (Puerto Rico and USA)
National poison centre: 0-800-333-0160 / (54 11) 4654-6648 (Argentina)

Side effects:

OTHER SAFETY INFORMATION

Constipation, after prolonged treatment.

Contraindications:

CONTRAINDICATIONS SECTION

Toxigenic Infections with e. Coli, Salmonella, Shigella and Pseudomembranous Colitis caused by antibiotics. In these cases, diarrhea plays a protective role, since it accelerates the elimination of micro-organisms, thus avoiding the proliferation of the same, the invasion of mucosa and the absorption of toxic products (enterotoxemia).

Dose:

DOSAGE & ADMINISTRATION SECTION

Dogs and cats: 0.1 mg/2.204 Lb. equivalent to 1 drop per 2.204 Lb. every 8 hours.

During the administration of the product, you will observe:
(1) Lower frequency in bowel movements.
(2) Lower volume of stool.
(3) Changes in consistency: from fluid to solid.
(4) Control of diarrhea.

Presentation:

STORAGE AND HANDLING SECTION

10 ml dropper

Keep between 40 degree and 95 degree F

Elaborado por: / Elaborated by:

SPL UNCLASSIFIED SECTION

HOLLIDAY-SCOTT S.A.
Int. Neyer 924 - (B1643GAT) Beccar
Buenos Aires - Argentina

Tel./Fax: (54-11) 4732-0222
E-mail: info@holliday.com.ar
Distributed in Puerto Rico by
International Med Distributors
PO BOX 627 Dorado PR 00646 - E-mail:
info@internationalmeddistributors.com

7 798042 365296

Antidiarrheal LOPERAMIDE Solution 10ml (58670-000-10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide BottleLoperamide BottleLoperamide InsertLoperamide InsertLoperamide OuterLoperamide Outer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1432291loperamide hydrochloride 2 MG/ML Oral SolutionSCD1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-137798042365296GTIN-13: 7798042365296
EAN-13: 7798042365296
GTIN storage (14 digits): 07798042365296
LoperamideOuter.jpg

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
58670-000-10Antidiarrheal LOPERAMIDE1 in 1 CARTONSOLUTION11
58670-000-10Antidiarrheal LOPERAMIDE10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58670-000ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]12 package rows20130731_273e6635-c3e6-4739-9fd0-d227c789c367.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 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58670-00058670-000-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB

Source Document#

Source XML

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 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacyd8a55fb6-bb57-42d6-8e20-67fc91f380972026-09-04WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEYYBA CORP568064c9-139d-7233-e063-6294a90a10d42026-08-10WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEREMEDYREPACK INC.3fdfc0e5-56a2-48a0-8ee6-390a194a29f32026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCbe99224e-dd49-4628-a5bf-ed8469ffd4a42026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLC74b9893a-18c3-4117-85c2-edab8e7b3b3b2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEKesin Pharma Corporation52e6ecc5-5f3d-9989-e063-6294a90af2dc2026-06-30WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESportpharm LLCeb93a17e-7daf-4a9e-94a1-442039a383bd2026-06-26WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8e4004be-bf79-4631-9e38-c4e7b67263132026-06-03WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEProficient Rx LP5e1358fc-76de-486a-80dd-7f41e037d9a02026-06-01WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d72026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECoupler LLC518bb0f0-88f2-1c95-e063-6294a90a722f2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepacka2594967-e737-4a23-a710-290ca0e6a2722026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
berkley and jensen anti diarrhealLOPERAMIDE HYDROCHLORIDEBJWCdc29a8e9-f916-49d2-b9a6-d2b4537d7b582026-05-08WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDESportpharm LLCac674e5a-94df-4a35-9854-4e66cc17e5092026-04-24WarningsName fallback
generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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