DEFAETON- peumus boldus leaf, dioscorea villosa tuber, strychnos ignatii seed, cynara scolymus whole, fumaria officinalis whole, frangula alnus bark, and rheum officinale root solution/ drops

DEFAETON by

Drug Labeling and Warnings

DEFAETON by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Naturheilmittel GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredients:
Cynara scloymus	12X
Dioscorea villosa	4X
Fumaria officinalis	6X
Strychnos ignatii (Ignatia)	6X
Peumus boldus (Boldo)	6X
Rhamnus frangula	8X
Rheum	8X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT

Contains 19% alcohol by volume.

Indications

For relief of occasional constipation. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 20 drops, 4 times per day. For pediatric dosages, consult your practitioner.

Warning

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Keep out of the reach of children.

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

QUESTIONS

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

DEFAETON™
Oral Drops

Homeopathic Medicine

For relief of
occasional constipation

3.34 FL OZ
(100 ml)

PEKANA®

INGREDIENTS AND APPEARANCE

DEFAETON 
peumus boldus leaf, dioscorea villosa tuber, strychnos ignatii seed, cynara scolymus whole, fumaria officinalis whole, frangula alnus bark, and rheum officinale root solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-133
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Peumus boldus Leaf (UNII: Q4EWM09M3O) (Peumus Boldus Leaf - UNII:Q4EWM09M3O)	Peumus boldus Leaf	6 [hp_X]  in 50 mL
Dioscorea villosa Tuber (UNII: IWY3IWX2G8) (Dioscorea Villosa Tuber - UNII:IWY3IWX2G8)	Dioscorea villosa Tuber	4 [hp_X]  in 50 mL
Strychnos ignatii Seed (UNII: 1NM3M2487K) (Strychnos ignatii Seed - UNII:1NM3M2487K)	Strychnos ignatii Seed	6 [hp_X]  in 50 mL
Cynara scolymus Whole (UNII: 9N3437ZUU0) (Cynara Scolymus Whole - UNII:9N3437ZUU0)	Cynara scolymus Whole	12 [hp_X]  in 50 mL
Fumaria officinalis Whole (UNII: DM87NN227Z) (Fumaria officinalis Whole - UNII:DM87NN227Z)	Fumaria officinalis Whole	6 [hp_X]  in 50 mL
Frangula Alnus Bark (UNII: S2D77IH61R) (Frangula Alnus Bark - UNII:S2D77IH61R)	Frangula Alnus Bark	8 [hp_X]  in 50 mL
Rheum officinale Root (UNII: A47JP5ZG9M) (Rheum officinale Root - UNII:A47JP5ZG9M)	Rheum officinale Root	8 [hp_X]  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59469-133-10	1 in 1 BOX	12/11/2008
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 59469-133-40	1 in 1 BOX	05/01/2017
2		100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		12/11/2008

Labeler - PEKANA Naturheilmittel GmbH (320344542)

Establishment
Name	Address	ID/FEI	Business Operations
PEKANA Naturheilmittel GmbH		320344542	MANUFACTURE(59469-133)