DailyMed - GUNA-RHINO NOSE (apis mellifera - aralia racemosa root - ascorbic acid - black currant - copper - euphorbia resinifera resin - european elderberry - helianthemum canadense - histamine dihydrochloride - human interleukin 12 - human interleukin-10- nonglycosylated - interferon gamma-1b - manganese gluconate - melilotus - onion - plantago major - rosa canina fruit - silver nitrate

NDC Code(s): 17089-419-23
Packager: Guna spa

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 21, 2018

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ACTIVE INGREDIENTS/PURPOSE
ALIUM CEPA            6X, 8X, 12X    EXPECTORANT - APIS MELLIFICA            12x, 30X, 200X    DECONGESTANT - ARALIA RACEMOSA            1X    ANTITUSSIVE ...

ALIUM CEPA            6X, 8X, 12X    EXPECTORANT
APIS MELLIFICA            12x, 30X, 200X    DECONGESTANT
ARALIA RACEMOSA            1X    ANTITUSSIVE
ARGENTUM NITRICUM        10X    ANALGESIC
ASCORBIC ACID            2X    ANTIOXIDANT
BLACK CURRANT, BARK         1X    DETOXIFICATION
CISTUS CANADENSIS        4X    HELPS BRONCHIAL SECRETION
CUPRUM METALLICUM        4X    ANTIOXIDANT
EUPHORBIUM OFFICINARUM        4X    MUCOLYTIC
HISTAMINUM HYDROCHLORICUM    30X, 200X    ANTI-INFLAMMATORY
INTERFERON GAMMA        4C    ANTIVIRAL
INTERLEUKIN 10            4C    ANTI-INFLAMMATORY
INTERLEUKIN 12            4C    SUPPORTS IMMUNE ACTIVITY
MANGANESE GLUCONATE        4X    DECONGESTANT
MELILOTUS OFFICINALIS         3X    DECONGESTANT
PLANTAGO MAJOR            2X    DETOXIFICATION
ROSA CANINA, BARK        1X    PAIN RELIEF
SAMBUCUS NIGRA            2X    ANTITUSSIVE

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USES
For the temporary relief of symptoms due to Seasonal Allergies such as: Sneezing, Watery Eyes, Runny nose

For the temporary relief of symptoms due to Seasonal Allergies such as: Sneezing, Watery Eyes, Runny nose

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

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

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PREGNANCY
If pregnant or breast-feeding ask a doctor before use

If pregnant or breast-feeding ask a doctor before use
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WARNINGS
Keep this and all medicines out of reach of children

Keep this and all medicines out of reach of children
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DIRECTIONS
Adults and children 12 years and older 2 sprays to each nostril , 3-5 times per day - Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day ...

Adults and children 12 years and older 2 sprays to each nostril , 3-5 times per day

Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day

Children under 6 years 1 spray to each nostril, 3 times per day

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QUESTIONS
Questions?: info@gunainc.com - Tel. (484) 223-3500

Questions?: info@gunainc.com
Tel. (484) 223-3500

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INDICATIONS & USAGE
Tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose.

Tilt head slightly forward, place tip of bottle into nose, compress bottle once for each spray, aiming towards the back of the nose.
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INACTIVE INGREDIENT
Inactive ingredients: Water, Orange juice, Potassium sorbate, Sodium benzoate

Inactive ingredients: Water, Orange juice, Potassium sorbate, Sodium benzoate
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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

GUNA-RHINO NOSE apis mellifera - aralia racemosa root - ascorbic acid - black currant - copper - euphorbia resinifera resin - european elderberry - helianthemum canadense - histamine dihydrochloride - human interleukin 12 - human interleukin-10 (nonglycosylated) - interferon gamma-1b - manganese gluconate - melilotus - onion - plantago major - rosa canina fruit - silver nitrate - spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-419
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	8 [hp_X] in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 30 mL
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU)	ARALIA RACEMOSA ROOT	1 [hp_X] in 30 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X] in 30 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	2 [hp_X] in 30 mL
BLACK CURRANT (UNII: 9755T40D11) (BLACK CURRANT - UNII:9755T40D11)	BLACK CURRANT	1 [hp_X] in 30 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3)	HELIANTHEMUM CANADENSE	4 [hp_X] in 30 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	4 [hp_X] in 30 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	4 [hp_X] in 30 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	200 [hp_X] in 30 mL
INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B - UNII:21K6M2I7AG)	INTERFERON GAMMA-1B	4 [hp_C] in 30 mL
INTERLEUKIN-10 (UNII: 9SC4O216V9) (INTERLEUKIN-10 - UNII:9SC4O216V9)	INTERLEUKIN-10	4 [hp_C] in 30 mL
HUMAN INTERLEUKIN 12 (UNII: 7B590791ER) (HUMAN INTERLEUKIN 12 - UNII:7B590791ER)	HUMAN INTERLEUKIN 12	4 [hp_C] in 30 mL
MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE GLUCONATE	4 [hp_X] in 30 mL
MELILOTUS (UNII: F22I9R6Q0X) (MELILOTUS - UNII:F22I9R6Q0X)	MELILOTUS	3 [hp_X] in 30 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	2 [hp_X] in 30 mL
ROSA CANINA FRUIT (UNII: 3TNW8D08V3) (ROSA CANINA FRUIT - UNII:3TNW8D08V3)	ROSA CANINA FRUIT	1 [hp_X] in 30 mL
EUROPEAN ELDERBERRY (UNII: BQY1UBX046) (EUROPEAN ELDERBERRY - UNII:BQY1UBX046)	EUROPEAN ELDERBERRY	2 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ORANGE JUICE (UNII: 5A9KE2L9L3)	0.6 mL in 30 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.03 mL in 30 mL
WATER (UNII: 059QF0KO0R)	15.9 mL in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.03 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-419-23	1 in 1 BOX	10/08/2011
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/27/2010

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-419)

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Published Date (What is this?)	Version	Files
Apr 8, 2019	2 (current)	download
Jan 13, 2011	1	download

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