FDA.reportPublic FDA data

CHELIDONIUM MAJUS

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:32:03

Label at a glance#

ProductCHELIDONIUM MAJUS 200CK
Active ingredientCHELIDONIUM MAJUS
Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Chelidonium Majus 200ck

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Digestion disorders with right upper back pain*

DOSAGE & ADMINISTRATION SECTION

Directions: (adults/children) Dissolve 5 pellets under the tongue once a day until symptoms are relieved or as directed by a physician.

USE

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

SUCROSE

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLAT_OLLOIS_CHELIDONIUM-MAJUS_200CKFLAT_OLLOIS_CHELIDONIUM-MAJUS_200CK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-4073-12025-02-11C16284748780-12cef2736-686e-d83d-e063-dadaa90ab31fSEVENE USA (as PLD) - CHELIDONIUM MAJUS 200CK (76472-4073)
76472-4073-12025-01-30C16284748780-12cef2736-686e-d83d-e063-dadaa90ab31fSEVENE USA (as PLD) - CHELIDONIUM MAJUS 200CK (76472-4073)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-4073-1CHELIDONIUM MAJUS200CK80 in 1 CYLINDERPELLET805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-4073CHELIDONIUM MAJUS 200CK (CHELIDONIUM MAJUS) PELLET [SEVENE USA]5Current NDC, Legacy NDC, 1 package rows20250213_ed9bd9e5-9de0-e529-e053-2995a90a397b.zip

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
76472-407376472-4073-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
CHELIDONIUM MAJUS7E889U5RNNACTIB

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
CHELIDONIUM MAJUS 200CKCHELIDONIUM MAJUSSEVENE USAed9bd9e5-9de0-e529-e053-2995a90a397b2025-02-11WarningsExact identifier
ndc (package): 76472-4073-1
ndc (product): 76472-4073
ndc11 (package): 76472407301
spl id: 2ddc34e3-fd46-deb3-e063-6394a90a8749
spl set id: ed9bd9e5-9de0-e529-e053-2995a90a397b

Reported adverse events (FAERS/openFDA)#

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