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 
BioActive Nutritional, Inc.

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.

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DRUG FACTS:

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:

For temporary relief of flatulence associated with constipation.

WARNINGS:

If pregnant or breast-feeding, ask a health care 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 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:

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

INDICATIONS:

For temporary relief of flatulence associated with constipation.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BioActive Nutritional

COLOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

COLOTOX

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0553
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (MEDICAGO SATIVA WHOLE - UNII:DJO934BRBD) MEDICAGO SATIVA 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
FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK3 [hp_X]  in 1 mL
RHEUM PALMATUM ROOT (UNII: G025DAL7CE) (RHEUM PALMATUM ROOT - UNII:G025DAL7CE) RHEUM PALMATUM ROOT3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER8 [hp_X]  in 1 mL
SUS SCROFA INTESTINAL MUCOSA (UNII: S61JFZ33Z1) (SUS SCROFA INTESTINAL MUCOSA - UNII:S61JFZ33Z1) SUS SCROFA INTESTINAL MUCOSA8 [hp_X]  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
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP12 [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
SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE12 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT12 [hp_X]  in 1 mL
BILIRUBIN (UNII: RFM9X3LJ49) (BILIRUBIN - UNII:RFM9X3LJ49) BILIRUBIN15 [hp_X]  in 1 mL
CREATINE (UNII: MU72812GK0) (CREATINE - UNII:MU72812GK0) CREATINE15 [hp_X]  in 1 mL
CREATININE (UNII: AYI8EX34EU) (CREATININE - UNII:AYI8EX34EU) CREATININE15 [hp_X]  in 1 mL
INDOLE (UNII: 8724FJW4M5) (INDOLE - UNII:8724FJW4M5) INDOLE15 [hp_X]  in 1 mL
SKATOLE (UNII: 9W945B5H7R) (SKATOLE - UNII:9W945B5H7R) SKATOLE15 [hp_X]  in 1 mL
PROTEUS MIRABILIS (UNII: C177VR41DV) (PROTEUS MIRABILIS - UNII:C177VR41DV) PROTEUS MIRABILIS20 [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 ENTERITIDIS12 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0553-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/23/2020
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0553) , api manufacture(43857-0553) , label(43857-0553) , pack(43857-0553)

Revised: 3/2020
Document Id: 17247af9-a56a-4990-9811-d401ed1bee92
Set id: ab978956-f991-4a45-8988-b8b2508bd85e
Version: 2
Effective Time: 20200324
 
BioActive Nutritional, Inc.