FDA.reportPublic FDA data

Taraxacum Officinale, Milk Thistle, and Chelidonium Majus Root

Manufacturer
Phytodyne Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:33

Label at a glance#

ProductTaraxacum comp.
Active ingredientTARAXACUM OFFICINALE, MILK THISTLE, CHELIDONIUM MAJUS ROOT
Label structure7 sections

Dosage and administration

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

Use

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For digestive discomfort

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Ingredients

OTC - ACTIVE INGREDIENT SECTION

Taraxacum officinale Ø (M) 40%, Carduus marianus Ø 30%, Chelidonium 4X (N) 30%

INACTIVE INGREDIENT SECTION

Alcohol: 53

TAMPER-EVIDENT

SPL UNCLASSIFIED SECTION

Do not use if tamper evident strip is broken from base of cap.

WARNING

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor if you are pregnant or nursing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children. In case of overdose, call a medical professional.

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CERES®
Homeopathic Medicine

Taraxacum comp.

Use: For digestive discomfort

Directions : Adults and children above 12 years: 2-5
drops 1-3 times daily in pure water before meals. Consult
a physician for use in children under 12 years of age.

0.67 fl.oz. (20ml)
Lot#:1234567A
EXP: 99.9999

Principal Display Panel - 20 ml Bottle Label
Principal Display Panel - 20 ml Bottle Label

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
13838-143413838-1434-1

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
TARAXACUM OFFICINALE39981FM375ACTIB
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS ROOTFLT36UCF0NACTIB
ALCOHOL3K9958V90MIACT

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
d8d4e7a4-705a-4d2e-b10c-6c84cb57630a586ac15e-530d-4df0-81c1-c55f1c8dbf4b2023-12-28WarningsExact identifier
spl id: d8d4e7a4-705a-4d2e-b10c-6c84cb57630a
spl set id: 586ac15e-530d-4df0-81c1-c55f1c8dbf4b

Reported adverse events (FAERS/openFDA)#

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