Label: ORGANDRAINEX- allium cepa, allium sativum, ambrosia artemisiaefolia, berberis vulgaris, chelidonium majus, collinsonia canadensis, cynara scolymus, petroselinum sativum, trifolium pratense, methylcobalamin, aloe, alpha-lipoicum acidum, palladium metallicum liquid
- NDC Code(s): 44911-0523-1
- Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 11, 2022
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ACTIVE INGREDIENTS:
(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:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ORGANDRAINEX
allium cepa, allium sativum, ambrosia artemisiaefolia, berberis vulgaris, chelidonium majus, collinsonia canadensis, cynara scolymus, petroselinum sativum, trifolium pratense, methylcobalamin, aloe, alpha-lipoicum acidum, palladium metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 3 [hp_X] in 1 mL GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 3 [hp_X] in 1 mL AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA WHOLE - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE 3 [hp_X] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 3 [hp_X] in 1 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS WHOLE - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 3 [hp_X] in 1 mL COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 3 [hp_X] in 1 mL CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF 3 [hp_X] in 1 mL PETROSELINUM CRISPUM WHOLE (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM WHOLE - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM WHOLE 3 [hp_X] in 1 mL TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 3 [hp_X] in 1 mL METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 4 [hp_X] in 1 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 6 [hp_X] in 1 mL ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (ALPHA LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID 12 [hp_X] in 1 mL PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0523-1 118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/29/2020 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/29/2020 03/03/2025 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0523) , api manufacture(44911-0523) , label(44911-0523) , pack(44911-0523)