Label: COLOTOX (alfalfa, berberis vulgaris, rhamnus purshiana, rheum (palmatum), taraxacum officinale, hepar bovine, small intestine (suis), aranea diadema, carbo animalis, carbo vegetabilis, cina, mandragora officinarum, mercurius solubilis, selenium metallicum, spigelia anthelmia, veratrum album, bilirubin, creatine, creatinine, indolum, skatolum, proteus- mirabilis, morgan gaertner liquid
- NDC Code(s): 43857-0553-1
- Packager: BioActive Nutritional, 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 17, 2024
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ACTIVE INGREDIENTS:
Alfalfa 3X, Berberis Vulgaris 3X, Rhamnus Purshiana 3X, Rheum (Palmatum) 3X, Taraxacum Officinale 3X, Hepar Bovine 8X, Small Intestine (Suis) 8X, Aranea Diadema 12X, Carbo Animalis 12X, Carbo Vegetabilis 12X, CINA 12X, Mandragora Officinarum 12X, Mercurius Solubilis 12X, Selenium Metallicum 12X, Spigelia Anthelmia 12X, Veratrum Album 12X, Bilirubin 15X, 30X, 200X, Creatine 15X, 30X, 200X, Creatinine 15X, 30X, 200X, Indolum 15X, 30X, 200X, Skatolum 15X, 30X, 200X, Proteus (Mirabilis) 20X, Morgan Gaertner 12C.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
COLOTOX
alfalfa, berberis vulgaris, rhamnus purshiana, rheum (palmatum), taraxacum officinale, hepar bovine, small intestine (suis), aranea diadema, carbo animalis, carbo vegetabilis, cina, mandragora officinarum, mercurius solubilis, selenium metallicum, spigelia anthelmia, veratrum album, bilirubin, creatine, creatinine, indolum, skatolum, proteus (mirabilis), morgan gaertner liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0553 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (MEDICAGO SATIVA WHOLE - UNII:DJO934BRBD) MEDICAGO SATIVA 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 FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK 3 [hp_X] in 1 mL RHEUM PALMATUM ROOT (UNII: G025DAL7CE) (RHEUM PALMATUM ROOT - UNII:G025DAL7CE) RHEUM PALMATUM ROOT 3 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 3 [hp_X] in 1 mL BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 8 [hp_X] in 1 mL SUS SCROFA INTESTINAL MUCOSA (UNII: S61JFZ33Z1) (SUS SCROFA INTESTINAL MUCOSA - UNII:S61JFZ33Z1) SUS SCROFA INTESTINAL MUCOSA 8 [hp_X] in 1 mL ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS 12 [hp_X] in 1 mL CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS 12 [hp_X] in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] in 1 mL ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 12 [hp_X] in 1 mL MANDRAGORA OFFICINARUM ROOT (UNII: I2XCB174VB) (MANDRAGORA OFFICINARUM ROOT - UNII:I2XCB174VB) MANDRAGORA OFFICINARUM ROOT 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 12 [hp_X] in 1 mL SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 12 [hp_X] in 1 mL VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 12 [hp_X] in 1 mL BILIRUBIN (UNII: RFM9X3LJ49) (BILIRUBIN - UNII:RFM9X3LJ49) BILIRUBIN 15 [hp_X] in 1 mL CREATINE (UNII: MU72812GK0) (CREATINE - UNII:MU72812GK0) CREATINE 15 [hp_X] in 1 mL CREATININE (UNII: AYI8EX34EU) (CREATININE - UNII:AYI8EX34EU) CREATININE 15 [hp_X] in 1 mL INDOLE (UNII: 8724FJW4M5) (INDOLE - UNII:8724FJW4M5) INDOLE 15 [hp_X] in 1 mL SKATOLE (UNII: 9W945B5H7R) (SKATOLE - UNII:9W945B5H7R) SKATOLE 15 [hp_X] in 1 mL PROTEUS MIRABILIS (UNII: C177VR41DV) (PROTEUS MIRABILIS - UNII:C177VR41DV) PROTEUS MIRABILIS 20 [hp_X] in 1 mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0553-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/23/2020 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0553) , api manufacture(43857-0553) , label(43857-0553) , pack(43857-0553)