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NDC 17089-0461-18 GUNA ALLERGY 12; 200; 12; 12; 12; 6; 6; 200; 6; 3; 12; 12; 30; 12; 6; 200 [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 Details

GUNA ALLERGY 12; 200; 12; 12; 12; 6; 6; 200; 6; 3; 12; 12; 30; 12; 6; 200 [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

GUNA ALLERGY is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; CUPRIC ACETATE; DRIMIA MARITIMA BULB; EPINEPHRINE; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MATRICARIA CHAMOMILLA WHOLE; ONION; SCHOENOCAULON OFFICINALE SEED; .

Product Information

NDC	17089-0461
Product ID	17089-461_b2580118-8598-5057-e053-2a95a90aab4e
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 ALLERGY
Proprietary Name Suffix	n/a
Non-Proprietary Name	Adrenalinum - allium cepa - ammonium carbonicum - apis mellifica - argentum nitricum - arsenicum album - cuprum aceticum - galphimia glauca - glandula suprarenalis suis - histaminum hydrochloricum - luffa operculata - matricaria chamomilla - mucosa nasali
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	12; 200; 12; 12; 12; 6; 6; 200; 6; 3; 12; 12; 30; 12; 6; 200
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
Substance Name	AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; CUPRIC ACETATE; DRIMIA MARITIMA BULB; EPINEPHRINE; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MATRICARIA CHAMOMILLA WHOLE; ONION; SCHOENOCAULON OFFICINALE SEED;
Labeler Name	Guna spa
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamin
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0461-18 (17089046118)

Pricing Information	N/A
NDC Package Code	17089-461-18
Billing NDC	17089046118
Package	1 BOTTLE, DROPPER in 1 BOX (17089-461-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ae6bd80d-2c70-1a3f-e053-2a95a90a2652 Details

ACTIVE INGREDIENTS/PURPOSE

CHAMOMILLA 3X RELIEVES INFLAMMATION

GLANDULA SUPRARENALIS SUIS 6X 12X 30X SUPPORTS METABOLISM

MUCOSA NASALIS SUIS 200X RELIEVES ALLERGY SYMPTOMS

SCILLA MARITIMA 12X 30X 200X RELIEVES DRY COUGH

SABADILLA 12X 30X 200X RELIEVES HAY FEVER

ALLIUM CEPA 12X 30X 200X RELIEVES RESPIRATORY CONGESTION

AMMONIUM CARBONICUM 12X 30X 200X RELIEVES RESPIRATORY CONGESTION

APIS MELLIFICA 200X HELPS REDUCE SWELLING

ARGENTUM NITRICUM 30X RELIEVES INFLAMMATION

ARSENICUM ALBUM 12X 30X 200X RELIEVES INFLAMMATION

CUPRUM ACETICUM 12X 30X 200X RELIEVES HAY FEVER, PERSISTENT COUGH

GALPHIMIA GLAUCA 6X 12X 200X RELIEVES HAY FEVER

LUFFA OPERCULATA 6X 12X 30X RELIEVES HAY FEVER

HISTAMINUM HYDROCHLORICUM 200X RELIEVES ALLERGY SYMPTOMS

NATRUM MURIATICUM 12X 30X 200X RELIEVES ALLERGY SYMPTOMS

ADRENALINUM 6X IMMUNE SUPPORT

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 accidental overdose, seek professional assistance or contact a poison control center immediately.
Contains ethyl alcohol 30%

WARNINGS

Keep out of the reach of children

DIRECTIONS

Take 15 minutes before meals.

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

QUESTIONS

Questions?: [email protected], tel. (484) 223-3500

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

PURPOSE

TEMPORARILY RELIEVES SYMPTOMS OF SEASONAL ALLERGIES SUCH AS:

SNEEZING
NASAL DISCHARGE
ITCHY, WATERY EYES

SPL UNCLASSIFIED SECTION

DO NOT USE

If tamper-evident seal is broken

stop use and ask doctor if symptoms persist more than 5 days

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA ALLERGY

adrenalinum - allium cepa - ammonium carbonicum - apis mellifica - argentum nitricum - arsenicum album - cuprum aceticum - galphimia glauca - glandula suprarenalis suis - histaminum hydrochloricum - luffa operculata - matricaria chamomilla - mucosa nasalis suis - natrum muriaticum - sabadilla - scilla maritima - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-461
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	200 [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
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	6 [hp_X] in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	200 [hp_X] in 30 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC ACETATE	12 [hp_X] in 30 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	30 [hp_X] in 30 mL
DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D)	DRIMIA MARITIMA BULB	12 [hp_X] in 30 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	6 [hp_X] in 30 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	12 [hp_X] in 30 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 30 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	6 [hp_X] in 30 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	3 [hp_X] in 30 mL
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (AMMONIUM CATION - UNII:54S68520I4)	AMMONIUM CARBONATE	12 [hp_X] in 30 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X] in 30 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 30 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY)	SUS SCROFA NASAL MUCOSA	200 [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:17089-461-18	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(17089-461)

Revised: 10/2020

Document Id: b2580118-8598-5057-e053-2a95a90aab4e

Set id: ae6bd80d-2c70-1a3f-e053-2a95a90a2652

Version: 2

Effective Time: 20201023

Search by Drug Name or NDC

GUNA ALLERGY 12; 200; 12; 12; 12; 6; 6; 200; 6; 3; 12; 12; 30; 12; 6; 200 [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

Product Information

Package

Package Images

NDC 17089-0461-18 (17089046118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ae6bd80d-2c70-1a3f-e053-2a95a90a2652 Details

ACTIVE INGREDIENTS/PURPOSE

WARNINGS

WARNINGS

DIRECTIONS

QUESTIONS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PURPOSE

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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