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NDC 13838-1434-01 Taraxacum comp. .3; .3; .4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Taraxacum comp. .3; .3; .4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Taraxacum comp. is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Phytodyne Inc.. The primary component is CHELIDONIUM MAJUS ROOT; MILK THISTLE; TARAXACUM OFFICINALE.

Product Information

NDC	13838-1434
Product ID	13838-1434_eae56137-22bd-4fbd-9f88-a047aa2a81df
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Taraxacum comp.
Proprietary Name Suffix	n/a
Non-Proprietary Name	Taraxacum Officinale, Milk Thistle, and Chelidonium Majus Root
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	.3; .3; .4
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	CHELIDONIUM MAJUS ROOT; MILK THISTLE; TARAXACUM OFFICINALE
Labeler Name	Phytodyne Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13838-1434-01 (13838143401)

Pricing Information	N/A
NDC Package Code	13838-1434-1
Billing NDC	13838143401
Package	20 mL in 1 BOTTLE, GLASS (13838-1434-1)
Marketing Start Date	2005-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 586ac15e-530d-4df0-81c1-c55f1c8dbf4b Details

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.

Ingredients

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

SPL UNCLASSIFIED SECTION

Alcohol: 53

TAMPER-EVIDENT

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

WARNING

Ask a doctor if you are pregnant or nursing.

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

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

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

INGREDIENTS AND APPEARANCE

TARAXACUM COMP.

taraxacum officinale, milk thistle, and chelidonium majus root solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13838-1434
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	0.4 [hp_X] in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	0.3 [hp_X] in 1 mL
CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N)	CHELIDONIUM MAJUS ROOT	0.3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13838-1434-1	20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/01/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		10/01/2005

Labeler - Phytodyne Inc. (164980927)

Revised: 12/2021

Document Id: eae56137-22bd-4fbd-9f88-a047aa2a81df

Set id: 586ac15e-530d-4df0-81c1-c55f1c8dbf4b

Version: 2

Effective Time: 20211214