Label at a glance#

ProductGUNA THROAT AND GUMS

Active ingredientACONITUM NAPELLUS, ARNICA MONTANA, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, WITCH HAZEL, CALCIUM SULFIDE, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, COMFREY ROOT

Label structure10 sections

Indications and uses

Relieves symptoms of inflammation of throat, gums and oral cavity, such as: pain hoarseness swollen tonsils toothache

Dosage and administration

Adults and children 12 years and older 2 sprays, 3-5 times per day Children between 12 and 6 years of age 1 spray, 3-5 times per day Children under 6 years consult a physician

Contacts and useful links#

PhoneLabel contact(484) 223-3500

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive ingredients: Ethyl alcohol 20 %, pine essential oil, lemon essential oil, polysorbate-80.

INDICATIONS & USAGE SECTION

Directions: Rotate the sprayer to the upright position. Spray as needed onto affected areas: mouth, throat, or gums.

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com

(484) 223-3500

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

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

Children under 6 years consult a physician

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS

WARNINGS SECTION

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a health professional promptly. ●Stop use and ask doctor if symptoms persist more than 3 days. ● If pregnant or breast-feeding ask a health care professional before use.● Keep out of reach of children. In case of overdose, get medical seek professional assistance or contact a Poison Control Center immediately. ● Contains ethyl alcohol 20%

USES

OTC - PURPOSE SECTION

Relieves symptoms of inflammation of throat, gums and oral cavity, such as:

pain
hoarseness
swollen tonsils
toothache

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Aconitum napellus 3X

Arnica montana 3X

Belladonna 4X

Echinacea 2X

Echinacea purpurea 2X

Hamamelis virginiana 2X

Hepar sulphuris calcareum 6X

Hypericum perforatum 3X

Millefolium 3X

Symphytum officinale 6X

RELIEF OF INFLAMMATION AND PAIN

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USTEG-4

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	5USTEG		5USTEG-4.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17089-479-27	GUNA THROAT AND GUMS	1 in 1 BOX	SPRAY	1		1
17089-479-27	GUNA THROAT AND GUMS	50 mL in 1 BOTTLE, SPRAY	SPRAY	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17089-479	GUNA THROAT AND GUMS (ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -) SPRAY [GUNA SPA]	1	Current NDC, Legacy NDC, 2 package rows	20210217_ba484531-ef7a-17ed-e053-2995a90a50b3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

GUNA THROAT AND GUMS
ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL
ALCOHOL
LEMON OIL
POLYSORBATE 80
ACONITUM NAPELLUS
ARNICA MONTANA
ATROPA BELLADONNA
ECHINACEA ANGUSTIFOLIA
ECHINACEA PURPUREA
WITCH HAZEL
CALCIUM SULFIDE
HYPERICUM PERFORATUM
ACHILLEA MILLEFOLIUM
COMFREY ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17089-479	17089-479-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL	9H7TY1ZV7Q	IACT
ALCOHOL	3K9958V90M	IACT
LEMON OIL	I9GRO824LL	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
ECHINACEA ANGUSTIFOLIA	VB06AV5US8	ACTIB
ECHINACEA PURPUREA	QI7G114Y98	ACTIB
WITCH HAZEL	101I4J0U34	ACTIB
CALCIUM SULFIDE	1MBW07J51Q	ACTIB
HYPERICUM PERFORATUM	XK4IUX8MNB	ACTIB
ACHILLEA MILLEFOLIUM	2FXJ6SW4PK	ACTIB
COMFREY ROOT	M9VVZ08EKQ	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA THROAT AND GUMS	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -	Guna spa	ba484531-ef7a-17ed-e053-2995a90a50b3	2021-02-17	Warnings	Exact identifier ndc (package): 17089-479-27 ndc (product): 17089-479 ndc11 (package): 17089047927 spl id: ba483fd7-f25d-cc95-e053-2995a90afd8a spl set id: ba484531-ef7a-17ed-e053-2995a90a50b3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.