Search by Drug Name or NDC

NDC 17089-0478-21 GUNA LIVER PLUS 3; 4; 6; 6; 8; 6; 2; 3; 6; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g Details

GUNA LIVER PLUS 3; 4; 6; 6; 8; 6; 2; 3; 6; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g

GUNA LIVER PLUS is a ORAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; FUMARIC ACID; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM PYRUVATE; SODIUM SULFATE; TARAXACUM OFFICINALE.

Product Information

NDC	17089-0478
Product ID	17089-478_d32e3bbc-f536-6d6f-e053-2995a90aa9f4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GUNA LIVER PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM PYRUVATE - SILYBUM MARIANUM SEED - CHELIDONIUM MAJUS - FUMARIC ACID - PORK LIVER - TARAXACUM OFFICINALE - LYCOPODIUM CLAVATUM SPORE - SODIUM SULFATE - PHOSPHORUS - BERBERIS VULGARIS ROOT BARK
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL
Active Ingredient Strength	3; 4; 6; 6; 8; 6; 2; 3; 6; 3
Active Ingredient Units	[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g
Substance Name	BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; FUMARIC ACID; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM PYRUVATE; SODIUM SULFATE; TARAXACUM OFFICINALE
Labeler Name	Guna spa
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0478-21 (17089047821)

Pricing Information	N/A
NDC Package Code	17089-478-21
Billing NDC	17089047821
Package	1 TUBE in 1 BOX (17089-478-21) / 4 g in 1 TUBE
Marketing Start Date	2021-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba44c46e-4509-2e4d-e053-2a95a90a9c95 Details

SPL UNCLASSIFIED SECTION

Inactive ingredient: Sucrose.

SPL UNCLASSIFIED SECTION

Questions?: [email protected]

tel. (484) 223-3500

SPL UNCLASSIFIED SECTION

Turn tube upside down and rotate cap to release pellets into cap.

Unscrew cap and without touching pellets tip them into the mouth under the tongue.

Allow to dissolve

Take 15 minutes before meals.

SPL UNCLASSIFIED SECTION

Adults and children 12 years and older 5 pellets 3 times per day

Children under 12 years of age consult a physician

SPL UNCLASSIFIED SECTION

Keep out of reach of children

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if symptoms persist more than 5 days or worsen.

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

Keep out of reach of children.

Gallstones, occlusion of the bile ducts, jaundice and any other unclear or persistent discomfort in the upper abdomen may be serious. Consult a doctor promptly if any of these symptoms occur

If you suffer from liver diseases, you should consult a doctor

SPL UNCLASSIFIED SECTION

Supports liver function, relieves minor symptoms of liver intoxication, such as:

abdominal pain and bloating
skin rashes

SPL UNCLASSIFIED SECTION

Berberis vulgaris 3X Supports liver and kidney drainage

Carduus marianus 2X Supports liver function

Chelidonium majus 4X Supports liver and gall bladder function

Fumaricum acidum 6X Supports detoxification

Hepar suis 6X Supports detoxification

Lycopodium clavatum 6X Supports liver function and drainage

Natrum pyruvicum 3X Supports detoxification, relieves skin rashes

Natrum sulphuricum 6X Supports detoxification

Phosphorus 8X Supports liver function

Taraxacum officinale 3X Supports liver function

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA LIVER PLUS

sodium pyruvate - silybum marianum seed - chelidonium majus - fumaric acid - pork liver - taraxacum officinale - lycopodium clavatum spore - sodium sulfate - phosphorus - berberis vulgaris root bark pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-478
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	2 [hp_X] in 4 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	4 [hp_X] in 4 g
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	6 [hp_X] in 4 g
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 4 g
SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR)	SODIUM PYRUVATE	3 [hp_X] in 4 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	6 [hp_X] in 4 g
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37, SULFATE ION - UNII:7IS9N8KPMG)	SODIUM SULFATE	6 [hp_X] in 4 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	8 [hp_X] in 4 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X] in 4 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 4 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-478-20	2 in 1 BOX	02/17/2021
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:17089-478-21	1 in 1 BOX	12/15/2021
2		4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-478)

Revised: 12/2021

Document Id: d32e3bbc-f536-6d6f-e053-2995a90aa9f4

Set id: ba44c46e-4509-2e4d-e053-2a95a90a9c95

Version: 2

Effective Time: 20211215

Search by Drug Name or NDC

NDC 17089-0478-21 GUNA LIVER PLUS 3; 4; 6; 6; 8; 6; 2; 3; 6; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g Details

GUNA LIVER PLUS 3; 4; 6; 6; 8; 6; 2; 3; 6; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g

Product Information

Package

Package Images

NDC 17089-0478-21 (17089047821)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba44c46e-4509-2e4d-e053-2a95a90a9c95 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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