FDA.reportPublic FDA data

FESTAL PLUS

Manufacturer
OASIS TRADING
Effective date
2018-11-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:21

Label at a glance#

ProductFESTAL PLUS
Active ingredientURSODIOL, PANCRELIPASE, DIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ursodeoxycholic Acid, Pancreatin, Simethione

OTC - PURPOSE SECTION

digestion

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

children under 7 years of age: consult a doctor
take 1-2 tablet as symptoms accur, as directed by a doctor

WARNINGS SECTION

Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
■ Do not take more than 4 tablet in 24 hours
■ Do not use the maximum dosage for more than 2 weeks
Keep out of reach of children

INACTIVE INGREDIENT SECTION

Dextrin, stearic acid, talc, polyethylene glycol 6000, Cellulase AP3

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
URSODIOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72689-0010-12020-01-31C16284748780-19d75b9d1-1473-f424-e053-dadaa90a57ce7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0010-1FESTAL PLUS10 in 1 BLISTER PACKTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0010FESTAL PLUS (URSODEOXYCHOLIC ACID, SIMETHICONE, PANCREATIN, CELLULASE AP3) TABLET [OASIS TRADING]1Legacy NDC, 1 package rows20181123_7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72689-001072689-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
URSODIOL724L30Y2QRACTIB
PANCRELIPASEFQ3DRG0N5KACTIM
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
7b4ab2b8-bdfb-9635-e053-2a91aa0acb4c7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c2018-11-22WarningsExact identifier
spl id: 7b4ab2b8-bdfb-9635-e053-2a91aa0acb4c
spl set id: 7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c

Reported adverse events (FAERS/openFDA)#

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