17089-293 NDC - GUNA-BOWEL (ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -)

Drug Information

Product NDC: 17089-293
Proprietary Name: GUNA-BOWEL
Non Proprietary Name: ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -
Active Ingredient(s): 2 [hp_X]/30mL ALOE; 6 [hp_X]/30mL ALUMINUM OXIDE; 6 [hp_X]/30mL BRYONIA ALBA ROOT; 2 [hp_X]/30mL CHELIDONIUM MAJUS; 2 [hp_X]/30mL CHOLECALCIFEROL; 2 [hp_X]/30mL COLLINSONIA; 2 [hp_X]/30mL FRANGULA ALNUS BARK; 2 [hp_X]/30mL NIACIN; 2 [hp_X]/30mL PANTOTHENIC ACID; 6 [hp_X]/30mL POTASSIUM CARBONATE; 2 [hp_X]/30mL RHUBARB; 2 [hp_X]/30mL SILYBUM MARIANUM SEED; 10 [hp_X]/30mL SKATOLE; 6 [hp_X]/30mL SODIUM CARBONATE; 6 [hp_X]/30mL STRYCHNOS NUX-VOMICA SEED; 12 [hp_X]/30mL SUS SCROFA COLON; 12 [hp_X]/30mL SUS SCROFA RECTUM; 2 [hp_X]/30mL TARAXACUM OFFICINALE; 4 [hp_X]/30mL THIAMINE
Administration Route(s): ORAL
Dosage Form(s): SOLUTION/ DROPS
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Nicotinic Acid [EPC]; Nicotinic Acids [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Vitamin D [CS]; Vitamin D [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Guna spa
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	5/23/2006

Package Information

No.	Package Code	Package Description	Billing Unit
1	17089-293-18	1 BOTTLE, DROPPER in 1 BOX (17089-293-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	17089-293	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	GUNA-BOWEL	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION/ DROPS	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	5/23/2006	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Guna spa	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLECALCIFEROL; COLLINSONIA; FRANGULA ALNUS BARK; NIACIN; PANTOTHENIC ACID; POTASSIUM CARBONATE; RHUBARB; SILYBUM MARIANUM SEED; SKATOLE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA COLON; SUS SCROFA RECTUM; TARAXACUM OFFICINALE; THIAMINE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	2; 6; 6; 2; 2; 2; 2; 2; 2; 6; 2; 2; 10; 6; 6; 12; 12; 2; 4
ACTIVE INGRED UNIT	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
PHARM CLASSES	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vitamin D [CS], Vitamin D [EPC]

Drug Information

Labeler Information

Package Information

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