Search by Drug Name or NDC

NDC 17089-0500-18 GUNA HEALTHY BRAIN 4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA HEALTHY BRAIN 4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA HEALTHY BRAIN is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is ACONITUM NAPELLUS; ALOE; ARNICA MONTANA; BARIUM OXALOSUCCINATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; SELENIUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA CEREBRUM; SUS SCROFA EMBRYO; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PLACENTA; THU.

Product Information

NDC	17089-0500
Product ID	17089-500_ba48694e-5cb1-22ef-e053-2995a90a9965
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 HEALTHY BRAIN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Citrullus colocynthis fruit pulp - ubidecarenone - sus scrifa adrenal gland - sus scrofa placenta - selenium - thuja occidentalis leafy twig - conium maculatum flowering top - sus scrofa embryo - aconitum napellus - aloe - barium oxalosuccinate - sus scro
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ACONITUM NAPELLUS; ALOE; ARNICA MONTANA; BARIUM OXALOSUCCINATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; SELENIUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA CEREBRUM; SUS SCROFA EMBRYO; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PLACENTA; THU
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 17089-0500-18 (17089050018)

Pricing Information	N/A
NDC Package Code	17089-500-18
Billing NDC	17089050018
Package	1 BOTTLE, DROPPER in 1 BOX (17089-500-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba486fa9-53d1-95d9-e053-2995a90af42d Details

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 Aloe. Do not use orally for more than 30 days.
Contains ethyl alcohol 30%

PREGNANCY

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

DIRECTIONS

Take 15 minutes before meals.

Adults and children twelve years and older: 20 drops in a little water, 2 times per day

Children under 12 years: consult a physician

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

WARNINGS

Keep out of reach of children.

QUESTIONS

Questions?

[email protected]

(484) 223-3500

SPL UNCLASSIFIED SECTION

Inactive ingredient: Ethyl alcohol 30%.

ACTIVE INGREDIENTS/PURPOSE

Aconitum napellus 4X Supports memory function

Aloe 4X Relieves fatigue

Arnica montana 3X Supports mental clarity

Barium oxalsuccinicum 6X Supports mental clarity

Cerebrum suis 6X Supports brain function

Colocynthis 4X Supports concentration

Conium maculatum 4X Supports memory function

Embryo suis 6X Supports memory function

Glandula suprarenalis suis 6X Supports concentration and memory function

Hypothalamus suis 6X Supports mental clarity and concentration

Placenta totalis suis 6X Supports mental clarity and concentration

Selenium metallicum 6X Relieves fatigue

Thuja occidentalis 8X Relieves fatigue

Ubidecarenonum 5X Relieves fatigue

USES

Helps mental clarity and focus

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUNA HEALTHY BRAIN

citrullus colocynthis fruit pulp - ubidecarenone - sus scrifa adrenal gland - sus scrofa placenta - selenium - thuja occidentalis leafy twig - conium maculatum flowering top - sus scrofa embryo - aconitum napellus - aloe - barium oxalosuccinate - sus scrofa cerebrum - arnica montana - sus scrofa hypothalamus - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-500
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	4 [hp_X] in 30 mL
SUS SCROFA EMBRYO (UNII: 9928MC12VO) (SUS SCROFA EMBRYO - UNII:9928MC12VO)	SUS SCROFA EMBRYO	6 [hp_X] in 30 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	6 [hp_X] in 30 mL
SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8)	SUS SCROFA PLACENTA	6 [hp_X] in 30 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	6 [hp_X] in 30 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	8 [hp_X] in 30 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	4 [hp_X] in 30 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X] in 30 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	4 [hp_X] in 30 mL
BARIUM OXALOSUCCINATE (UNII: L7A49804ZQ) (BARIUM CATION - UNII:V645272HLN)	BARIUM OXALOSUCCINATE	6 [hp_X] in 30 mL
SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532)	SUS SCROFA CEREBRUM	6 [hp_X] in 30 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 30 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	6 [hp_X] in 30 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	5 [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:17089-500-18	1 in 1 BOX	02/17/2021
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		02/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-500)

Revised: 2/2021

Document Id: ba48694e-5cb1-22ef-e053-2995a90a9965

Set id: ba486fa9-53d1-95d9-e053-2995a90af42d

Version: 1

Effective Time: 20210217

Search by Drug Name or NDC

NDC 17089-0500-18 GUNA HEALTHY BRAIN 4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA HEALTHY BRAIN 4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0500-18 (17089050018)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ba486fa9-53d1-95d9-e053-2995a90af42d Details

WARNINGS

PREGNANCY

DIRECTIONS

SPL UNCLASSIFIED SECTION

WARNINGS

QUESTIONS

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS/PURPOSE

USES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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