Dizziness - Vertigo

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:56

Label at a glance#

ProductDizziness - Vertigo
Active ingredientWormwood, Aconitum Napellus, Antimony Potassium Tartrate, Atropa Belladonna, Bryonia Alba Root, Phenol, Colchicum Autumnale Bulb, Conium Maculatum Flowering Top, Iron, Gelsemium Sempervirens Root, Nitroglycerin, Hyoscyamus Niger, Ipecac, Iris Versicolor Root, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Kerosene, Phosphorus, Sepia Officinalis Juice, Symphoricarpos Albus Fruit, Tobacco Leaf, Theridion Curassavicum, Ginger, Echinacea, Unspecified, Hypericum Perforatum, Passiflora Incarnata Flowering Top, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Dizziness - Vertigo  Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Absinthium 20x, Aconitum nap. 20x, Antimon. tart. 20x, Belladonna 20x, Bryonia 20x, Carbolicum acidum 20x, Colchicum 20x, Conium 20x, Ferrum metallicum 20x, Gelsemium 20x, Glonoinum 20x, Hyoscyamus 20x, Ipecac. 20x, Iris versicolor 20x, Lycopodium 20x, Nux vom. 20x, Petroleum 20x, Phosphorus 20x, Sepia 20x, Symphoricarpus racemosus 20x, Tabacum 20x, Theridion 20x, Zingiber 20x, Echinacea 8x, Hypericum 8x, Passiflora 8x, Valeriana 8x, Echinacea 3x, Hypericum 3x, Passiflora 3x, Valeriana 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children. 

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4508-12020-01-31C16284748780-19d75b9d0-9751-f424-e053-dadaa90a57ceDizziness - Vertigo
55714-4508-22020-01-31C16284748780-19d75b9d0-9751-f424-e053-dadaa90a57ceDizziness - Vertigo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4508-1Dizziness - Vertigo29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-4508-2Dizziness - Vertigo59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4508DIZZINESS - VERTIGO (ABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 2 package rows20130829_f76d4389-dd27-ca13-dc55-e41dcfa2f72b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V32
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Colchicum Autumnale BulbACTIVE INGREDIENT993QHL78E62
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3712
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q2
GingerACTIVE INGREDIENTC5529G5JPQ2
Hyoscyamus NigerACTIVE INGREDIENT4WRK2153H32
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB2
IpecacACTIVE INGREDIENT62I3C8233L2
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC2
IronACTIVE INGREDIENTE1UOL152H72
KeroseneACTIVE INGREDIENT1C89KKC04E2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
NitroglycerinACTIVE INGREDIENTG59M7S0WS32
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O2
PhenolACTIVE INGREDIENT339NCG44TV2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Symphoricarpos Albus FruitACTIVE INGREDIENT873JZU3ASZ2
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L2
Tobacco LeafACTIVE INGREDIENT6YR2608RSU2
ValerianACTIVE INGREDIENTJWF5YAW3QW2
WormwoodACTIVE INGREDIENTF84709P2XV2
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
Antimony Cation (3+)ACTIVE MOIETY069647RPT52
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Colchicum Autumnale BulbACTIVE MOIETY993QHL78E62
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3712
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q2
GingerACTIVE MOIETYC5529G5JPQ2
Hyoscyamus NigerACTIVE MOIETY4WRK2153H32
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB2
IpecacACTIVE MOIETY62I3C8233L2
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC2
IronACTIVE MOIETYE1UOL152H72
KeroseneACTIVE MOIETY1C89KKC04E2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
NitroglycerinACTIVE MOIETYG59M7S0WS32
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O2
PhenolACTIVE MOIETY339NCG44TV2
PhosphorusACTIVE MOIETY27YLU75U4W2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Symphoricarpos Albus FruitACTIVE MOIETY873JZU3ASZ2
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L2
Tobacco LeafACTIVE MOIETY6YR2608RSU2
ValerianACTIVE MOIETYJWF5YAW3QW2
WormwoodACTIVE MOIETYF84709P2XV2
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-450855714-4508-1, 55714-4508-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 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
24f89fb0-b485-42ba-f060-264f60505616f76d4389-dd27-ca13-dc55-e41dcfa2f72b2011-06-01WarningsExact identifier
spl id: 24f89fb0-b485-42ba-f060-264f60505616
spl set id: f76d4389-dd27-ca13-dc55-e41dcfa2f72b

Reported adverse events (FAERS/openFDA)#

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