Label: ORGANDRAINEX- allium cepa, allium sativum, ambrosia artemisiaefolia, berberis vulgaris, chelidonium majus, collinsonia canadensis, cynara scolymus, methylcobalamin, petroselinum sativum, trifolium pratense, aloe, alpha-lipoicum acidum, palladium metallicum liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 28, 2020

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  • ACTIVE INGREDIENTS:

    Allium Cepa 3X, 6X, 12X, 30X, 60X, 200X, Allium Sativum 3X, 6X, 12X, 30X, 60X, 200X, Ambrosia Artemisiaefolia 3X, 6X, 12X, 30X, 60X, 200X, Berberis Vulgaris 3X, 6X, 12X, 30X, 60X, 200X, Chelidonium Majus 3X, 6X, 12X, 30X, 60X, 200X, Collinsonia Canadensis 3X, 6X, 12X, 30X, 60X, 200X, Cynara Scolymus 3X, 6X, 12X, 30X, 60X, 200X, Methylcobalamin 3X, 6X, 12X, 30X, 60X, 200X, Petroselinum Sativum 3X, 6X, 12X, 30X, 60X, 200X, Trifolium Pratense 3X, 6X, 12X, 30X, 60X, 200X, Aloe 6X, 12X, 30X, 60X, 200X, alpha-Lipoicum Acidum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X.

  • 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   800.868.8078

  • 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, methylcobalamin, petroselinum sativum, trifolium pratense, aloe, alpha-lipoicum acidum, palladium metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0457
    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 (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA3 [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 (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [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
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN3 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE6 [hp_X]  in 1 mL
    THIOCTIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) THIOCTIC ACID12 [hp_X]  in 1 mL
    PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0457-1118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/01/201807/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/201807/26/2023
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0457) , api manufacture(44911-0457) , label(44911-0457) , pack(44911-0457)