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

  • 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, Berberis Vulgaris 6X, 12X, 30X, 60X, 200X, Chelidonium Majus 6X, 12X, 30X, 60X, 200X, Collinsonia Canadensis 6X, Methylcobalamin 6X, 12X, 30X, 60X, 200X, Petroselinum Sativum 6X, 12X, 30X, 60X, 200X, Trifolium Pratense 6X, 12X, 30X, 60X, 200X; Aloe 7X, 12X, 30X, 60X, 200X, 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, Petroselinum Sativum 3X, Trifolium Pratense 3X; Ambrosia Artemisiaefolia 3X, 6X, Cynara Scolymus 3X, 6X; Methylcobalamin 4X.

  • INDICATIONS:

    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:

    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:

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

  • DIRECTIONS:

    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:

    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:

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

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    ORGANDRAINEX

    4 fl. oz. (118 ml)

    Organdrainex

  • 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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION3 [hp_X]  in 1 mL
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC3 [hp_X]  in 1 mL
    AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE3 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE3 [hp_X]  in 1 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT3 [hp_X]  in 1 mL
    CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF3 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM WHOLE (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM WHOLE3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN4 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE7 [hp_X]  in 1 mL
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID12 [hp_X]  in 1 mL
    PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0660-1118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/11/2022
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0660) , api manufacture(44911-0660) , label(44911-0660) , pack(44911-0660)
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