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NDC 17089-0463-18 GUNA ARTHRO RELIEF 3; 8; 3; 6; 6; 6; 6; 6; 3; 4; 3; 8; 6; 4; 6; 6; 6; 6; 6; 6; 6; 6 [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; [hp_X]/3 Details

GUNA ARTHRO RELIEF 3; 8; 3; 6; 6; 6; 6; 6; 3; 4; 3; 8; 6; 4; 6; 6; 6; 6; 6; 6; 6; 6 [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; [hp_X]/3

GUNA ARTHRO RELIEF is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BLACK COHOSH; BRYONIA ALBA ROOT; CHLORINE; COLCHICUM AUTUMNALE BULB; NADIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM DIETHYL OXALACETATE; SODIUM SULFATE; SOLANUM D.

Product Information

NDC	17089-0463
Product ID	17089-463_b258aa33-c259-1343-e053-2a95a90af0c0
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 ARTHRO RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	arteria suis - alpha ketoglutaricum acidum - alpha lipoicum acidum - ascorbicum acidum - barium oxalsuccinicum - bryonia alba - calcarea carbonica - cartilago suis - chlorinum - cimicifuga racemosa - colchicum autumnale - dulcamara - embryo suis - funicul
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	3; 8; 3; 6; 6; 6; 6; 6; 3; 4; 3; 8; 6; 4; 6; 6; 6; 6; 6; 6; 6; 6
Active Ingredient Units	[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; [hp_X]/3
Substance Name	.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BLACK COHOSH; BRYONIA ALBA ROOT; CHLORINE; COLCHICUM AUTUMNALE BULB; NADIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM DIETHYL OXALACETATE; SODIUM SULFATE; SOLANUM D
Labeler Name	Guna spa
Pharmaceutical Class	Ascorbic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vitamin C [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0463-18 (17089046318)

Pricing Information	N/A
NDC Package Code	17089-463-18
Billing NDC	17089046318
Package	1 BOTTLE, DROPPER in 1 BOX (17089-463-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aebb990a-65bc-54ed-e053-2995a90a5682 Details

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?

[email protected]

(484) 223-3500

WARNINGS

Keep out of reach of children

DIRECTIONS

Adults and children 12 years and older 20 drops in a little water 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water 2 times per day

Children under 6 years consult a physician

PREGNANCY

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

WARNINGS

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health care professional before use.
Keep out of reach of children. In case of overdose, seek professional assistance or contact a Poison Control Center immediately.
Contains ethyl alcohol 30%

USES

Temporarily relieves minor arthritic symptoms, such as:

Joint stiffness
Joint pain
Joint swelling and inflammation

ACTIVE INGREDIENTS/PURPOSE

Arteria suis 6X Helps reduce swelling

Calcarea carbonica 4X Supports bone metabolism

Embryo suis 6X Supports cell metabolism

Funiculus umbilicalis suis 6X Supports bone metabolism

Glandula suprarenalis suis 6X Supports metabolism

Placenta totalis suis 6X Supports metabolism

Ascorbicum acidum 3X Antioxidant

Bryonia alba 6X, 8X, 12X Relieves muscle and joint pain

Cartilago suis 6X Relieves stiffness

Chlorinum 6X Relieves pain

Cimicifuga racemosa 6X, 8X, 12X Relieves rheumatic pain

Colchicum autumnale 6X, 8X, 12X Relieves rheumatic pain

Dulcamara 6X, 8X, 12X Relieves rheumatic pain

Natrum sulphuricum 8X Relieves rheumatic pain

Rhus toxicodendron 6X, 8X, 12X Relieves rheumatic pain

Vena suis 6X Helps reduce swelling

Alpha-ketoglutaricum acidum 3X Supports metabolism

Barium oxalsuccinicum 6X Supports metabolism

Natrum oxalaceticum 3X Supports metabolism

Nadidum 3X Relieves stiffness

Sulphur 4X Relieves stiffness

Alpha-lipoicum acidum 8X Supports metabolism

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA ARTHRO RELIEF

arteria suis - alpha ketoglutaricum acidum - alpha lipoicum acidum - ascorbicum acidum - barium oxalsuccinicum - bryonia alba - calcarea carbonica - cartilago suis - chlorinum - cimicifuga racemosa - colchicum autumnale - dulcamara - embryo suis - funiculus umbilicalis suis - glandula suprarenalis suis - nadidum - natrum oxalaceticum - natrum sulphuricum - placenta totalis suis - rhus toxicodendron - sulphur- vena suis - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-463
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	4 [hp_X] in 30 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFATE	8 [hp_X] in 30 mL
.ALPHA.-KETOGLUTARIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	.ALPHA.-KETOGLUTARIC ACID	3 [hp_X] in 30 mL
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y)	.ALPHA.-LIPOIC ACID	8 [hp_X] in 30 mL
SUS SCROFA ARTERY (UNII: 63O327782Q) (SUS SCROFA ARTERY - UNII:63O327782Q)	SUS SCROFA ARTERY	6 [hp_X] in 30 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	3 [hp_X] in 30 mL
BARIUM OXALOSUCCINATE (UNII: L7A49804ZQ) (BARIUM CATION - UNII:V645272HLN)	BARIUM OXALOSUCCINATE	6 [hp_X] in 30 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 30 mL
SUS SCROFA CARTILAGE (UNII: 73ECW5WG2F) (SUS SCROFA CARTILAGE - UNII:73ECW5WG2F)	SUS SCROFA CARTILAGE	6 [hp_X] in 30 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820)	CHLORINE	6 [hp_X] in 30 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	6 [hp_X] in 30 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	6 [hp_X] in 30 mL
SUS SCROFA EMBRYO (UNII: 9928MC12VO) (SUS SCROFA EMBRYO - UNII:9928MC12VO)	SUS SCROFA EMBRYO	6 [hp_X] in 30 mL
SOLANUM DULCAMARA FLOWER (UNII: W6J1279A6K) (SOLANUM DULCAMARA FLOWER - UNII:W6J1279A6K)	SOLANUM DULCAMARA FLOWER	6 [hp_X] in 30 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H)	SUS SCROFA UMBILICAL CORD	6 [hp_X] in 30 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	6 [hp_X] in 30 mL
NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK)	NADIDE	3 [hp_X] in 30 mL
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7)	SODIUM DIETHYL OXALACETATE	3 [hp_X] in 30 mL
SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8)	SUS SCROFA PLACENTA	6 [hp_X] in 30 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X] in 30 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	4 [hp_X] in 30 mL
SUS SCROFA VEIN (UNII: 2510RH3I89) (SUS SCROFA VEIN - UNII:2510RH3I89)	SUS SCROFA VEIN	6 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-463-18	1 in 1 BOX	09/24/2020
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/24/2020

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-463)

Revised: 10/2020

Document Id: b258aa33-c259-1343-e053-2a95a90af0c0

Set id: aebb990a-65bc-54ed-e053-2995a90a5682

Version: 2

Effective Time: 20201023

Search by Drug Name or NDC

Product Information

Package

Package Images

NDC 17089-0463-18 (17089046318)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL aebb990a-65bc-54ed-e053-2995a90a5682 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

DIRECTIONS

PREGNANCY

WARNINGS

USES

ACTIVE INGREDIENTS/PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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