Search by Drug Name or NDC

NDC 17089-0476-21 GUNA HAY FEVER RELIEF 200; 30; 5; 4; 200; 8; 30; 6; 6; 4; 30 [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; [hp_X]/4g Details

GUNA HAY FEVER RELIEF 200; 30; 5; 4; 200; 8; 30; 6; 6; 4; 30 [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; [hp_X]/4g

GUNA HAY FEVER RELIEF is a ORAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; MANGANESE; ONION; SCHOENOCAULON OFFICINALE SEED; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; SULFUR.

Product Information

NDC	17089-0476
Product ID	17089-476_d3322d60-dd44-8e96-e053-2995a90a54b0
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 HAY FEVER RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	strychnos nux vomica seed - histamine dihydrochloride - manganese - schoenocaulon officinale seed - apis mellifera - arsenic trioxide - silver nitrate - onion - euphrasia stricta - galphimia glauca flowering top - sulfur -
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL
Active Ingredient Strength	200; 30; 5; 4; 200; 8; 30; 6; 6; 4; 30
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; [hp_X]/4g
Substance Name	APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; MANGANESE; ONION; SCHOENOCAULON OFFICINALE SEED; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; SULFUR
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Hi
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0476-21 (17089047621)

Pricing Information	N/A
NDC Package Code	17089-476-21
Billing NDC	17089047621
Package	1 TUBE in 1 BOX (17089-476-21) / 4 g in 1 TUBE
Marketing Start Date	2021-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8db4fc6-f235-6f2b-e053-2a95a90a186f Details

SPL UNCLASSIFIED SECTION

Temporarily relieves hay fever symptoms, such as:

● sneezing

● coughing

● inflamed, runny nose

QUESTIONS

Questions?

[email protected]

(484) 223-3500

WARNINGS

Keep out of reach of children

PREGNANCY

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

USES

Temporarily relieves hay fever symptoms, such as:

● sneezing

● coughing

● inflamed, runny nose

WARNINGS

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

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 professional before use.
Do not use more than the recommended dose.
Keep out of reach of children.

ACTIVE INGREDIENTS/PURPOSE

Allium cepa 30X Relieves sneezing, runny nose

Apis mellifica 200X Helps reduce swelling

Galphimia glauca 4X Relieves sneezing, coughing, blocked nose

Argentum nitricum 6X Relieves sneezing, runny nose

Arsenicum album 30X Relieves allergy symptoms

Euphrasia officinalis 5X Relieves inflamed nose and eye mucosa

Histaminum hydrochloricum 200X Relieves allergy symptoms

Manganum metallicum 8X Relieves hoarseness

Nux vomica 4X Relieves sneezing, coughing, blocked nose

Sabadilla 6X Relieves sneezing, coughing, blocked nose

Sulphur 30X Relieves inflamed nose and eye mucosa

DIRECTIONS

Turn tube upside down and rotate cap to release pellets into cap. ● Unscrew cap and, without touching the pellets, place them 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 between 12 and 6 years of age 3 pellets 3 times per day
Children under 6 years 1 pellet 3 times per day to be disoolved into a little water

SPL UNCLASSIFIED SECTION

Inactive ingredient: Sucrose.

SPL UNCLASSIFIED SECTION

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA HAY FEVER RELIEF

strychnos nux vomica seed - histamine dihydrochloride - manganese - schoenocaulon officinale seed - apis mellifera - arsenic trioxide - silver nitrate - onion - euphrasia stricta - galphimia glauca flowering top - sulfur - pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-476
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_X] in 4 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	200 [hp_X] in 4 g
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P)	MANGANESE	8 [hp_X] in 4 g
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X] in 4 g
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	30 [hp_X] in 4 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	200 [hp_X] in 4 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	6 [hp_X] in 4 g
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	5 [hp_X] in 4 g
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	4 [hp_X] in 4 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_X] in 4 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_X] in 4 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)	4 g in 4 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-476-20	2 in 1 BOX	02/17/2021
1		4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:17089-476-21	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(17089-476)

Revised: 12/2021

Document Id: d3322d60-dd44-8e96-e053-2995a90a54b0

Set id: b8db4fc6-f235-6f2b-e053-2a95a90a186f

Version: 3

Effective Time: 20211215

Search by Drug Name or NDC

NDC 17089-0476-21 GUNA HAY FEVER RELIEF 200; 30; 5; 4; 200; 8; 30; 6; 6; 4; 30 [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; [hp_X]/4g Details

GUNA HAY FEVER RELIEF 200; 30; 5; 4; 200; 8; 30; 6; 6; 4; 30 [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; [hp_X]/4g

Product Information

Package

Package Images

NDC 17089-0476-21 (17089047621)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b8db4fc6-f235-6f2b-e053-2a95a90a186f Details

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

PREGNANCY

USES

WARNINGS

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS/PURPOSE

DIRECTIONS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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