FDA.reportPublic FDA data

Antiemetic Gastrokinetic PILERAN

Manufacturer
Holliday-Scott S.A. | Ipca Laboratories Limited
Effective date
2013-07-18
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:39:37

Label at a glance#

ProductAntiemetic Gastrokinetic PILERAN
Active ingredientMETOCLOPRAMIDE HYDROCHLORIDE
Label structure10 sections

Storage and handling

20 ml dropper Keep between 41 degree and 86 degree F

Label contents#

Full prescribing information#

Antiemetic Gastrokinetic PILERAN

DESCRIPTION SECTION

Metoclopramide Oral way Drops for dogs and Cats. PILERAN is a potent antiemetic drug which acts at central and peripheral levels and exerts a gastrokinetic effect at gastric, pyloric, duodenal and jejunal level.

Formula:

OTC - ACTIVE INGREDIENT SECTION

Each ml of oral solution contains:
Metoclopramide hydrochloride...........5 mg Vehicle q.s.

Indications:

INDICATIONS & USAGE SECTION

Vomiting of different etiology. Nausea. Gastric emptiness. Reflux espphagitis Preparation for x-ray exams of the gastrointestinal tract.

Precautions:

PRECAUTIONS SECTION

It is not recommended during the early stages of pregnancy. Side effects are dose-dependent and include nervousness, hyperexcitability, restlessness, depression and constipation in case of long-term therapy.

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)

Contraindications:

CONTRAINDICATIONS SECTION

Presence of gastrointestinal sharp foreign bodies. Mechanical obstruction. Digestive perforation. It should not be used in combination with anticholinergics or opiates.

Dose:

DOSAGE & ADMINISTRATION SECTION

Dogs and cats: 1 ml (20 drops) per 22 Lb of body weight every 6 - 8 hs.

Presentation:

STORAGE AND HANDLING SECTION

20 ml dropper

Keep between 41 degree and 86 degree F

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 365395

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pileran BottlePileran BottlePileran InsertPileran InsertPileran OuterPileran Outer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431142metoclopramide hydrochloride 5 MG/ML Oral Solution [Pileran]SBD1
1431136metoclopramide hydrochloride 5 MG/ML Oral SolutionSCD1
1431142Pileran 5 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58670-001-20Antiemetic Gastrokinetic PILERAN1 in 1 CARTONSOLUTION11
58670-001-20Antiemetic Gastrokinetic PILERAN20 mL in 1 BOTTLE, DROPPERSOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58670-001ANTIEMETIC GASTROKINETIC PILERAN (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]12 package rows20130718_923d6054-9409-464c-8083-4cee81f6ccb4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVD1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I461

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
58670-00158670-001-20

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
METOCLOPRAMIDE HYDROCHLORIDEW1792A2RVDACTIM

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.3cd4b274-6176-4e5b-9765-4f50763bd58f2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEAvenacy, LLCdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a662026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50a3cf38-66dc-4fa5-8a45-adf959c987ab2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
GIMOTIMETOCLOPRAMIDE HYDROCHLORIDEEvoke Pharma, Inc.95269b1f-779c-4ca0-9f86-e74e677f99002026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
ReglanMETOCLOPRAMIDE HYDROCHLORIDEANI Pharmaceuticals, Inc.de55c133-eb08-4a35-91a2-5dc0930273972026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell RX, LLCdc364325-dd39-4259-a348-3760eccdca4b2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.c4ab34f2-25e6-47bd-9dde-1f4baf469f0d2025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3cc8ca5b-8b71-4c77-a181-9ce154597b9a2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEGenus Lifesciences Inc.74358569-7a24-4a59-a7fc-500d2341d6cb2024-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEFresenius Kabi USA, LLCcc739885-e10e-4bcb-a781-c726c518f3d12023-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLCd163182b-582d-df59-e053-2995a90a300b2023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa2020-12-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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