FDA.reportPublic FDA data

Chelidonium Colocynthis Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:45:22

Label at a glance#

ProductChelidonium Colocynthis Special Order
Active ingredientCITRULLUS COLOCYNTHIS FRUIT, CHELIDONIUM MAJUS ROOT
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Chelidonium (Greater celandine) 2X, Colocynthis (Bitter apple) 3X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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. Contains traces of lactose. If pregnant or nursing, consult a doctor before use.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chelidonium Colocynthis Special OrderChelidonium Colocynthis Special Order

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-307448951-3074-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRULLUS COLOCYNTHIS FRUIT0E49E3V9U6ACTIB
CHELIDONIUM MAJUS ROOTFLT36UCF0NACTIB

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
c46bf2bb-e2d5-9b8c-e053-2a95a90a4ffa7b97fb7a-e862-0e07-e053-2991aa0a813c2021-06-10WarningsExact identifier
spl set id: 7b97fb7a-e862-0e07-e053-2991aa0a813c