Search by Drug Name or NDC

NDC 17089-0479-27 GUNA THROAT AND GUMS 3; 3; 3; 4; 6; 6; 2; 2; 3; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Details

GUNA THROAT AND GUMS 3; 3; 3; 4; 6; 6; 2; 2; 3; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL

GUNA THROAT AND GUMS is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HYPERICUM PERFORATUM; WITCH HAZEL.

Product Information

NDC	17089-0479
Product ID	17089-479_ba483fd7-f25d-cc95-e053-2995a90afd8a
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 THROAT AND GUMS
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	3; 3; 3; 4; 6; 6; 2; 2; 3; 2
Active Ingredient Units	[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
Substance Name	ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HYPERICUM PERFORATUM; WITCH HAZEL
Labeler Name	Guna spa
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0479-27 (17089047927)

Pricing Information	N/A
NDC Package Code	17089-479-27
Billing NDC	17089047927
Package	1 BOTTLE, SPRAY in 1 BOX (17089-479-27) / 50 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba484531-ef7a-17ed-e053-2995a90a50b3 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

QUESTIONS

Questions?: [email protected]

(484) 223-3500

DIRECTIONS

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

Keep out of reach of children

PREGNANCY

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

WARNINGS

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

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

pain
hoarseness
swollen tonsils
toothache

ACTIVE INGREDIENTS/PURPOSE

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-479
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X] in 50 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 50 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X] in 50 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	2 [hp_X] in 50 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	2 [hp_X] in 50 mL
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	2 [hp_X] in 50 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_X] in 50 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 50 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	3 [hp_X] in 50 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X] in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ABIES SACHALINENSIS VAR. SACHALINENSIS OIL (UNII: 9H7TY1ZV7Q)
ALCOHOL (UNII: 3K9958V90M)
LEMON OIL (UNII: I9GRO824LL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-479-27	1 in 1 BOX	02/17/2021
1		50 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		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-479)

Revised: 2/2021

Document Id: ba483fd7-f25d-cc95-e053-2995a90afd8a

Set id: ba484531-ef7a-17ed-e053-2995a90a50b3

Version: 1

Effective Time: 20210217

Search by Drug Name or NDC

NDC 17089-0479-27 GUNA THROAT AND GUMS 3; 3; 3; 4; 6; 6; 2; 2; 3; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Details

GUNA THROAT AND GUMS 3; 3; 3; 4; 6; 6; 2; 2; 3; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL

Product Information

Package

Package Images

NDC 17089-0479-27 (17089047927)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba484531-ef7a-17ed-e053-2995a90a50b3 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

QUESTIONS

DIRECTIONS

WARNINGS

PREGNANCY

WARNINGS

USES

ACTIVE INGREDIENTS/PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?