FESTAL PLUS

Manufacturer
Lydia Co., Ltd.
Effective date
2024-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:18:36

Label at a glance#

ProductFESTAL PLUS
Active ingredientPANCRELIPASE, DIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cellulase AP3

Pancreatin

Simethicone

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

DOSAGE & ADMINISTRATION SECTION

for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0038-1FESTAL PLUS10 in 1 PACKAGETABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0038FESTAL PLUS (CELLULASE AP3 , PANCREATIN, SIMETHICONE) TABLET [LYDIA CO., LTD.]2Current NDC, 1 package rows20240904_212f5059-da04-595d-e063-6394a90acc64.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-003872988-0038-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANCRELIPASEFQ3DRG0N5KACTIM
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FESTAL PLUSCELLULASE AP3 , PANCREATIN, SIMETHICONELydia Co., Ltd.212f5059-da04-595d-e063-6394a90acc642024-09-03WarningsExact identifier
ndc (package): 72988-0038-1
ndc (product): 72988-0038
ndc11 (package): 72988003801
spl id: 2130c5e0-13f6-33a5-e063-6394a90aa1e7
spl set id: 212f5059-da04-595d-e063-6394a90acc64

Reported adverse events (FAERS/openFDA)#

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