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NDC 17089-0469-18 GUNA MOOD SUPPORT 12; 30; 3; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA MOOD SUPPORT 12; 30; 3; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA MOOD SUPPORT is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ARSENIC TRIOXIDE; GOLD; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE.

Product Information

NDC	17089-0469
Product ID	17089-469_b2e68392-b15d-1cf9-e053-2a95a90a5834
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 MOOD SUPPORT
Proprietary Name Suffix	n/a
Non-Proprietary Name	arsenic trioxide - sepia officinalis juice - lycopodium clavatum spore - hypericum perforatum - gold -
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	12; 30; 3; 30; 30
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ARSENIC TRIOXIDE; GOLD; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE
Labeler Name	Guna spa
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0469-18 (17089046918)

Pricing Information	N/A
NDC Package Code	17089-469-18
Billing NDC	17089046918
Package	1 BOTTLE, DROPPER in 1 BOX (17089-469-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b2e68383-d6ca-e534-e053-2995a90a053f Details

USES

Temporary relief of mild anxiety and restlessness

ACTIVE INGREDIENTS/PURPOSE

ARSENICUM ALBUM 12X RELIEVES MILD ANXIETY, RELIEVES RESTLESSNESS

AURUM METALLICUM 30X RELIEVES MILD ANXIETY, RELIEVES RESTLESSNESS

HYPERICUM PERFORATUM 3X RELIEVES MILD ANXIETY, RELIEVES RESTLESSNESS

LYCOPODIUM CLAVATUM 30X RELIEVES MILD ANXIETY, RELIEVES RESTLESSNESS

SEPIA OFFICINALIS 30X RELIEVES MILD ANXIETY, RELIEVES RESTLESSNESS

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

QUESTIONS

Questions?

[email protected]

Tel. (484) 223-3500

WARNINGS

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

DIRECTIONS

Take 15 minutes before meals.

Adults and children twelve 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

PREGNANCY

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

WARNINGS

Stop use and ask doctor if symptoms worsen or 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%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA MOOD SUPPORT

arsenic trioxide - sepia officinalis juice - lycopodium clavatum spore - hypericum perforatum - gold - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-469
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X] in 30 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 30 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 30 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	30 [hp_X] in 30 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [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:17089-469-18	1 in 1 BOX	11/15/2020
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		11/15/2020

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-469)

Revised: 1/2021

Document Id: b2e68392-b15d-1cf9-e053-2a95a90a5834

Set id: b2e68383-d6ca-e534-e053-2995a90a053f

Version: 1

Effective Time: 20210117

Search by Drug Name or NDC

NDC 17089-0469-18 GUNA MOOD SUPPORT 12; 30; 3; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA MOOD SUPPORT 12; 30; 3; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0469-18 (17089046918)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b2e68383-d6ca-e534-e053-2995a90a053f Details

USES

ACTIVE INGREDIENTS/PURPOSE

SPL UNCLASSIFIED SECTION

QUESTIONS

WARNINGS

SPL UNCLASSIFIED SECTION

DIRECTIONS

PREGNANCY

WARNINGS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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