Search by Drug Name or NDC

NDC 17089-0465-18 GUNA PAIN MANAGEMENT 2; 30; 3; 2; 6; 6; 12; 3; 6; 2; 6; 4; 8 [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 Details

GUNA PAIN MANAGEMENT 2; 30; 3; 2; 6; 6; 12; 3; 6; 2; 6; 4; 8 [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

GUNA PAIN MANAGEMENT is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ACHILLEA MILLEFOLIUM WHOLE; APIS MELLIFERA; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA ALBA ROOT; COMFREY ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; MATRICARIA CHAMOMILLA WHOLE; PORK LIVER; RUTA GRAVEOLENS FLOW.

Product Information

NDC	17089-0465
Product ID	17089-465_af5b9acf-ede8-0899-e053-2a95a90a1706
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 PAIN MANAGEMENT
Proprietary Name Suffix	n/a
Non-Proprietary Name	achillea millefolium whole - bellis perennis whole - matricaria chamomilla whole - toxicodendron pubescens whole - ruta graveolens flowering top - comfrey root - apis mellifera - bryonia alba root - histamine hydrochloride - hypericum perforatum - kalmia
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	2; 30; 3; 2; 6; 6; 12; 3; 6; 2; 6; 4; 8
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
Substance Name	ACHILLEA MILLEFOLIUM WHOLE; APIS MELLIFERA; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA ALBA ROOT; COMFREY ROOT; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; MATRICARIA CHAMOMILLA WHOLE; PORK LIVER; RUTA GRAVEOLENS FLOW
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0465-18 (17089046518)

Pricing Information	N/A
NDC Package Code	17089-465-18
Billing NDC	17089046518
Package	1 BOTTLE, DROPPER in 1 BOX (17089-465-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL af5bad63-6d57-2260-e053-2995a90afb7e Details

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?

[email protected]

Tel. (484) 223-3500

WARNINGS

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

DIRECTIONS

Take 15 minutes before meals.

Adults and children twelve 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 profesisonal before use.

WARNINGS

Stop use and ask doctor if symptoms worsen or 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 accidental overdose, seek professional assistance or contact a poison control center immediately
Contains ethyl alcohol 30%

ACTIVE INGREDIENTS/PURPOSE

Millefolium 2X Relieves pain

Bellis perennis 2X Relieves muscle soreness, sprains

Apis mellifica 30X Helps reduce swelling

Bryonia 6X Relieves muscle and joint pain

Chamomilla 2X Relieves inflammation

Histaminum hydroc. 12X Relieves burning, redness

Hepar suis 6X Relieves pain

Hypericum perf. 3X Relieves pain

Kalmia latifolia 6X Relieves pain

Rhus tox 8X Relieves pain

Ruta graveolens 4X Relieves pain

Symphytum officinale 6X Relieves pain

Arnica montana 3X Relieves inflammation

USES

Relieves swelling and pain in cases of:

muscle aches, cramps
minor injuries, bruises
toothache

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA PAIN MANAGEMENT

achillea millefolium whole - bellis perennis whole - matricaria chamomilla whole - toxicodendron pubescens whole - ruta graveolens flowering top - comfrey root - apis mellifera - bryonia alba root - histamine hydrochloride - hypericum perforatum - kalmia latifolia leaf - arnica montana whole - pork liver - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-465
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 30 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 30 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 30 mL
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	3 [hp_X] in 30 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 30 mL
BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS WHOLE - UNII:2HU33I03UY)	BELLIS PERENNIS WHOLE	2 [hp_X] in 30 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	2 [hp_X] in 30 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	8 [hp_X] in 30 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	4 [hp_X] in 30 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	6 [hp_X] in 30 mL
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM WHOLE - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM WHOLE	2 [hp_X] in 30 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X] in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	30 [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:17089-465-18	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(17089-465)

Revised: 9/2020

Document Id: af5b9acf-ede8-0899-e053-2a95a90a1706

Set id: af5bad63-6d57-2260-e053-2995a90afb7e

Version: 1

Effective Time: 20200915

Search by Drug Name or NDC

NDC 17089-0465-18 GUNA PAIN MANAGEMENT 2; 30; 3; 2; 6; 6; 12; 3; 6; 2; 6; 4; 8 [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 Details

GUNA PAIN MANAGEMENT 2; 30; 3; 2; 6; 6; 12; 3; 6; 2; 6; 4; 8 [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

Product Information

Package

Package Images

NDC 17089-0465-18 (17089046518)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL af5bad63-6d57-2260-e053-2995a90afb7e Details

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

SPL UNCLASSIFIED SECTION

DIRECTIONS

PREGNANCY

WARNINGS

ACTIVE INGREDIENTS/PURPOSE

USES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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