FDA.reportPublic FDA data

GUNA-DIZZY

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:10:41

Label at a glance#

ProductGUNA-DIZZY
Active ingredientEPINEPHRINE, .ALPHA.-KETOGLUTARIC ACID, AMBERGRIS, SUS SCROFA ARTERY, SUS SCROFA CEREBELLUM, QUININE SALICYLATE, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, FUMARIC ACID, MALIC ACID, MELATONIN, MINERAL OIL, SUS SCROFA PLACENTA, PTERIDIUM AQUILINUM ROOT, PYRIDOXINE HYDROCHLORIDE, QUINHYDRONE, TOBACCO LEAF, THIAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporary relief of motion sickness symptoms such as: Lightheadedness Dizziness

Dosage and administration

Adults and children 12 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 5 drops in a glass of water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ADRENALINUM            6X    METABOLIC SUPPORT
ALFA KETOGLUTARICUM ACIDUM    6X    METABOLIC SUPPORT
AMBRA GIRSEA            6X    DIZZINESS
ARTERY                       6X    SUPPORTS BLOOD FLOW THROUGH VESSELS
CEREBELLUM             6X    MONITORS POSTURE
CHININUM SALICYLICUM        6X    FATIGUE
COCCULUS INDICUS        4X    DIZZINESS
CONIUM MACULATUM        3X    DIZZINESS
FUMARICUM ACIDUM        6X    ANTI-INFLAMMATORY
MALIC ACID            6X    METABOLIC SUPPORT
MELATONIN            4C    HORMONAL SUPPORT
PETROLEUM            8X    DIZZINESS
PLACENTA TOTALIS        6X    SUPPORTS BLOOD FLOW
PTERIDIUM AQUILINUM        8X    DETOXIFICATION
PYRIDOXINUM HYDROCHLORICUM    6X    METABOLIC SUPPORT
QUINHYDRONE            6X    METABOLIC SUPPORT
TABACUM                6X    DIZZINESS
THIAMINUM HYDROCHLORICUM    4X    METABOLIC SUPPORT

USES

OTC - PURPOSE SECTION

Temporary relief of motion sickness symptoms such as:

  • Lightheadedness
  • Dizziness

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION



Keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION





Adults and children 12 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 5 drops in a glass of water, 2 times per day

QUESTIONS

OTC - QUESTIONS SECTION

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

INDICATIONS & USAGE SECTION

Take 15 minutes before meals

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Ethyl alcohol 30%,

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USDIZ-REV05-07-05-185USDIZ-REV05-07-05-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-306-18GUNA-DIZZY30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303
17089-306-18GUNA-DIZZY1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-306GUNA-DIZZY (.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -) SOLUTION/ DROPS [GUNA SPA]3Current NDC, Legacy NDC, 2 package rows20190103_c5f4a798-e628-4388-a98d-7449dd92f2d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-KETOGLUTARIC ACIDACTIVE INGREDIENT8ID597Z82X2
AMBERGRISACTIVE INGREDIENTXTC0D02P6C2
ANAMIRTA COCCULUS SEEDACTIVE INGREDIENT810258W28U2
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF3712
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH2
FUMARIC ACIDACTIVE INGREDIENT88XHZ131312
MALIC ACIDACTIVE INGREDIENT817L1N4CKP2
MELATONINACTIVE INGREDIENTJL5DK93RCL2
MINERAL OILACTIVE INGREDIENTT5L8T28FGP2
PTERIDIUM AQUILINUM ROOTACTIVE INGREDIENTHQJ5Z3SOIV2
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV2
QUINHYDRONEACTIVE INGREDIENTP4A66LQ3QJ2
QUININE SALICYLATEACTIVE INGREDIENT6DY04L71DR2
SUS SCROFA ARTERYACTIVE INGREDIENT63O327782Q2
SUS SCROFA CEREBELLUMACTIVE INGREDIENT49NGK53TPQ2
SUS SCROFA PLACENTAACTIVE INGREDIENTC8CV8867O82
THIAMINE HYDROCHLORIDEACTIVE INGREDIENTM572600E5P2
TOBACCO LEAFACTIVE INGREDIENT6YR2608RSU2
.ALPHA.-KETOGLUTARIC ACIDACTIVE MOIETY8ID597Z82X2
AMBERGRISACTIVE MOIETYXTC0D02P6C2
ANAMIRTA COCCULUS SEEDACTIVE MOIETY810258W28U2
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF3712
EPINEPHRINEACTIVE MOIETYYKH834O4BH2
FUMARIC ACIDACTIVE MOIETY88XHZ131312
MALIC ACIDACTIVE MOIETY817L1N4CKP2
MELATONINACTIVE MOIETYJL5DK93RCL2
MINERAL OILACTIVE MOIETYT5L8T28FGP2
PTERIDIUM AQUILINUM ROOTACTIVE MOIETYHQJ5Z3SOIV2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z2
QUINHYDRONEACTIVE MOIETYP4A66LQ3QJ2
QUININE SALICYLATEACTIVE MOIETY6DY04L71DR2
SUS SCROFA ARTERYACTIVE MOIETY63O327782Q2
SUS SCROFA CEREBELLUMACTIVE MOIETY49NGK53TPQ2
SUS SCROFA PLACENTAACTIVE MOIETYC8CV8867O82
THIAMINEACTIVE MOIETYX66NSO3N352
TOBACCO LEAFACTIVE MOIETY6YR2608RSU2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-30617089-306-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
EPINEPHRINEYKH834O4BHACTIB
.ALPHA.-KETOGLUTARIC ACID8ID597Z82XACTIB
AMBERGRISXTC0D02P6CACTIB
SUS SCROFA ARTERY63O327782QACTIB
SUS SCROFA CEREBELLUM49NGK53TPQACTIB
QUININE SALICYLATE6DY04L71DRACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
FUMARIC ACID88XHZ13131ACTIB
MALIC ACID817L1N4CKPACTIB
MELATONINJL5DK93RCLACTIB
MINERAL OILT5L8T28FGPACTIB
SUS SCROFA PLACENTAC8CV8867O8ACTIB
PTERIDIUM AQUILINUM ROOTHQJ5Z3SOIVACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
QUINHYDRONEP4A66LQ3QJACTIB
TOBACCO LEAF6YR2608RSUACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-DIZZY.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -Guna spac5f4a798-e628-4388-a98d-7449dd92f2d62018-12-21WarningsExact identifier
ndc (package): 17089-306-18
ndc (product): 17089-306
ndc11 (package): 17089030618
spl id: 7e7be278-8d19-71c4-e053-2991aa0a377c
spl set id: c5f4a798-e628-4388-a98d-7449dd92f2d6

Reported adverse events (FAERS/openFDA)#

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