FDA.reportPublic FDA data

Chelidonium Rosa

Manufacturer
Uriel Pharmacy Inc.
Effective date
2019-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:08:36

Label at a glance#

ProductChelidonium Rosa
Active ingredientSILICON DIOXIDE, FERRIC OXIDE RED, SEDUM ROSEUM WHOLE, CHELIDONIUM MAJUS ROOT, RUTA GRAVEOLENS FLOWERING TOP, LARIX DECIDUA RESIN
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Hematite (Red iron ore) 3X, Rosa (Garden rose) 3X, Chelidonium (Greater celandine) 4X, Ruta (Rue) 4X, Chrysolith (Silicate of magnesium and iron) 6X, Resina laricis (Larch resin) 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt, Boric acid, Sodium bicarbonate, Fennel oil

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.
Opened on:_________________

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chelidonium RosaChelidonium RosaChelidonium Rosa 10mlChelidonium Rosa 10ml

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-322948951-3229-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
BORIC ACIDR57ZHV85D4IACT
FENNEL OIL59AAO5F6HTIACT
FERRIC OXIDE RED1K09F3G675ACTIB
SEDUM ROSEUM WHOLERH0WP583U3ACTIB
CHELIDONIUM MAJUS ROOTFLT36UCF0NACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
LARIX DECIDUA RESINAD8LJ73GQFACTIB

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
07ed828a-4382-faa2-e063-6394a90a70f694194f88-8c55-5f86-e053-2a95a90a9b292023-10-17WarningsExact identifier
spl set id: 94194f88-8c55-5f86-e053-2a95a90a9b29

Reported adverse events (FAERS/openFDA)#

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