FDA.reportPublic FDA data

Organdrainex

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2022-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:49

Label at a glance#

ProductOrgandrainex
Active ingredientONION, GARLIC, AMBROSIA ARTEMISIIFOLIA WHOLE, BERBERIS VULGARIS ROOT BARK, CHELIDONIUM MAJUS WHOLE, COLLINSONIA CANADENSIS ROOT, CYNARA SCOLYMUS LEAF, PETROSELINUM CRISPUM WHOLE, TRIFOLIUM PRATENSE FLOWER, METHYLCOBALAMIN, ALOE, ALPHA LIPOIC ACID, PALLADIUM
Label structure9 sections

Dosage and administration

Adults, 1 teaspoon twice daily. Children, 2-9 years, 1/2 teaspoon twice daily, or as directed by a physician. Take between meals without food. Consult a physician for use in children under 6 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop) 1.62% Allium Cepa 6X, 12X, 30X, 60X, 200X Allium Sativum 6X, 12X, 30X, 60X, 200X, Aloe 6X, 12X, 30X, 60X, 200X, Berberis Vulgaris 6X, 12X, 30X, 60X, 200X, Chelidonium Majus 6X, 12X, 30X, 60X, 200X, Collinsonia Canadensis 6X, 12X, 30X, 60X, 200X, Methylcobalamin 6X, 12X, 30X, 60X, 200X, Petroselinum Sativum 6X, 12X, 30X, 60X, 200X, Trifolium Pratense 6X, 12X, 30X, 60X, 200X, Alpha-Lipoicum Acidum 12X, 30X, 60X, 200X, Ambrosia Artemisiaefolia 12X, 30X, 60X, 200X, Cynara Scolymus 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X. 0.10% of Allium Cepa 3X, Allium Sativum 3X, Berberis Vulgaris 3X, Chelidonium Majus 3X, Collinsonia Canadensis 3X, Methylcobalamin 4X, Petroselinum Sativum 3X, Trifolium Pratense 3X, Ambrosia Artemisiaefolia 3X, 6X, Cynara Scolymus 3X, 6X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with decreased lymphatic drainage of the organs, such as fatigue, headache, lymphatic swelling, and bad effects from sedentary habits.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults, 1 teaspoon twice daily. Children, 2-9 years, 1/2 teaspoon twice daily, or as directed by a physician. Take between meals without food.

Consult a physician for use in children under 6 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with decreased lymphatic drainage of the organs, such as fatigue, headache, lymphatic swelling, and bad effects from sedentary habits.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Demineralized Water, 1.13% Ethanol, Potassium Sorbate.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

ORGANDRAINEX

4 fl. oz. (118 ml)

OrgandrainexOrgandrainex

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0523-12022-10-11C16284748780-1d6a99b39-bb40-a426-e053-dadaa90af4c2Drug Facts:
44911-0523-12022-01-28C16284748780-1d6a99b39-bb40-a426-e053-dadaa90af4c2Drug Facts:

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-052344911-0523-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
GARLICV1V998DC17ACTIB
AMBROSIA ARTEMISIIFOLIA WHOLE9W34L2CQ9AACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
CYNARA SCOLYMUS LEAFB71UA545DEACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
METHYLCOBALAMINBR1SN1JS2WACTIB
ALOEV5VD430YW9ACTIB
ALPHA LIPOIC ACID73Y7P0K73YACTIB
PALLADIUM5TWQ1V240MACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
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
6eed96f6-639a-4325-9eae-f735d62410432d3cd4bf-76ea-44c3-a9fd-759530d8f9432022-10-11WarningsExact identifier
spl id: 6eed96f6-639a-4325-9eae-f735d6241043
spl set id: 2d3cd4bf-76ea-44c3-a9fd-759530d8f943

Reported adverse events (FAERS/openFDA)#

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