FDA.reportPublic FDA data

PEDOXAN Extract

Manufacturer
I World Pharmaceutical Co., Ltd. | I World Pharmaceutical Co., Ltd
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:28

Label at a glance#

ProductPEDOXAN Extract
Active ingredientTANGERINE, ACETAMINOPHEN, SAPOSHNIKOVIA DIVARICATA ROOT, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide

OTC - PURPOSE SECTION

minor aches and pain from colds, headache fever

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

for adults take 1 pouch per intake, 3 times a day, before or between meals

WARNINGS SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Atractylodes Rhizome(KP), Aurantium lmmature Fruit(KHP), Perilla Leaf(KP), Poria(KP)

Platycodon Root(KP), Cnidium Rhizome(KP), Bupleurum Root(KP), Pueraria Root(KP)

Schizonepeta Spike(KP), Angelica Decursiva Root(KHP), Ostericum Root(KP)

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TANGERINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73442-0014-1PEDOXAN Extract3 g in 1 POUCHGRANULE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73442-0014PEDOXAN EXTRACT (CITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) GRANULE [I WORLD PHARMACEUTICAL CO., LTD.]1Current NDC, Legacy NDC, 1 package rows20200916_af69d604-180c-702f-e053-2a95a90a2ae4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73442-001473442-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
TANGERINEKH3E3096OOACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACETAMINOPHEN362O9ITL9DACTIB
SAPOSHNIKOVIA DIVARICATA ROOT8H84LFK2QDACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
ndc (package): 73442-0014-1
ndc (product): 73442-0014
ndc11 (package): 73442001401
spl id: af69d604-180d-702f-e053-2a95a90a2ae4
spl set id: af69d604-180c-702f-e053-2a95a90a2ae4

Reported adverse events (FAERS/openFDA)#

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