Label: COLOSODE- taraxacum officinale, berberis vulgaris, rhamnus purshiana, rheum, cina, arsenicum album, aloe socotrina, colostrum, gallbladder, hepar bovinum, 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 June 28, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Taraxacum officinale 1X, Berberis vulgaris 3X, Rhamnus purshiana 3X, Rheum 3X, Cina 3X, 6X, 12X, Arsenicum album 6X, Aloe socotrina 6X, 12X, 30X, Colostrum 8X, Gallbladder 8X, 12X, Hepar bovinum 8X, 12X, Carbo vegetabilis 8X, 30X, Intestine 8X, 30X, Aranea diadema 12X, Carbo animalis 12X, Enterococcinum 12X, Mandragora officinarum 12X, Mercurius solubilis 12X, Selenium metallicum 12X, Veratrum album 12X, Lactobacillus 15X, Clostridium botulinum 30X, 60X, Proteus mirabilis 30X, 60X, Salmonella enteritidis 30X, 60X, Pseudomonas aeruginosa 30X, 60X, Yersinia enterocolitica 30X, 60X, Indolum 30X, 60X, Clostridium perfringens 15C, 30C, 60C, Escherchia coli 32C, Giardia lamblia 12C, 30C, 60C, 200C.


  • PURPOSE

    INDICATIONS:  Aids in the relief of acute food poisoning, and removal of bowel toxin residue.


  • WARNINGS

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

    If pregnant or breast-feeding, ask a health professional before use.

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





  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


  • 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.


  • INDICATIONS & USAGE

    INDICATIONS:  Aids in the relief of acute food poisoning, and removal of bowel toxin residue.


  • QUESTIONS

    Distributed by

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, South Carolina


  • PRINCIPAL DISPLAY PANEL


    Synergy Formulas

    COLOSODE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Colosode

  • INGREDIENTS AND APPEARANCE
    COLOSODE 
    taraxacum officinale, berberis vulgaris, rhamnus purshiana, rheum, cina, arsenicum album, aloe socotrina, colostrum, gallbladder, hepar bovinum, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0349
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE1 [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
    FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK3 [hp_X]  in 1 mL
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT3 [hp_X]  in 1 mL
    ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE6 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE30 [hp_X]  in 1 mL
    SUS SCROFA GALLBLADDER (UNII: B6A98VOI9I) (SUS SCROFA GALLBLADDER - UNII:B6A98VOI9I) SUS SCROFA GALLBLADDER12 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER12 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_X]  in 1 mL
    PORK INTESTINE (UNII: 40GMI0R60L) (PORK INTESTINE - UNII:40GMI0R60L) PORK INTESTINE30 [hp_X]  in 1 mL
    ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI32 [hp_C]  in 1 mL
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS12 [hp_X]  in 1 mL
    CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS12 [hp_X]  in 1 mL
    ENTEROCOCCUS FAECALIS (UNII: 15E04LZ9CT) (ENTEROCOCCUS FAECALIS - UNII:15E04LZ9CT) ENTEROCOCCUS FAECALIS12 [hp_X]  in 1 mL
    MANDRAGORA OFFICINARUM ROOT (UNII: I2XCB174VB) (MANDRAGORA OFFICINARUM ROOT - UNII:I2XCB174VB) MANDRAGORA OFFICINARUM ROOT12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM12 [hp_X]  in 1 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT12 [hp_X]  in 1 mL
    SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS60 [hp_X]  in 1 mL
    PROTEUS MIRABILIS (UNII: C177VR41DV) (PROTEUS MIRABILIS - UNII:C177VR41DV) PROTEUS MIRABILIS60 [hp_X]  in 1 mL
    PSEUDOMONAS AERUGINOSA (UNII: Y793W5V55N) (PSEUDOMONAS AERUGINOSA - UNII:Y793W5V55N) PSEUDOMONAS AERUGINOSA60 [hp_X]  in 1 mL
    INDOLE (UNII: 8724FJW4M5) (INDOLE - UNII:8724FJW4M5) INDOLE200 [hp_X]  in 1 mL
    CLOSTRIDIUM PERFRINGENS (UNII: OVP6XX033E) (CLOSTRIDIUM PERFRINGENS - UNII:OVP6XX033E) CLOSTRIDIUM PERFRINGENS60 [hp_C]  in 1 mL
    BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (BOTULINUM TOXIN TYPE A - UNII:E211KPY694) BOTULINUM TOXIN TYPE A60 [hp_X]  in 1 mL
    GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA200 [hp_C]  in 1 mL
    YERSINIA ENTEROCOLITICA (UNII: AUL7Y5Z806) (YERSINIA ENTEROCOLITICA - UNII:AUL7Y5Z806) YERSINIA ENTEROCOLITICA60 [hp_X]  in 1 mL
    COLOSTRUM HUMAN (UNII: VB6F65I6F5) (COLOSTRUM HUMAN - UNII:VB6F65I6F5) COLOSTRUM HUMAN8 [hp_X]  in 1 mL
    SUS SCROFA GALLBLADDER (UNII: B6A98VOI9I) (SUS SCROFA GALLBLADDER - UNII:B6A98VOI9I) SUS SCROFA GALLBLADDER 12 [hp_X]  in 1 mL
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS 15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0349-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/29/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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