Colosode
FDA Label NDC 57520-0349

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Colosode (NDC 57520-0349). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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.


Otc - 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.


Otc - 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.


Otc - Questions

Distributed by

SYNERGY FORMULAS, INC.

251 West Road

Campobello, South Carolina


Package Label.Principal Display Panel


Synergy Formulas

COLOSODE

HOMEOPATHIC

2 FL OZ (60 ml)

Colosode (Mm1)

Colosode (Mm1)


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