FDA.reportPublic FDA data

Motion Sickness

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:14

Label at a glance#

ProductMotion Sickness
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

Motion Sickness    Formulated for associated symptoms of the effects or the sensation of movement such as dizziness, discomfort, headache, nausea and disorientation.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Absinthium 15x, Aconitum nap. 15x, Antimon. tart. 15x, Belladonna 15x, Bryonia 15x, Carbolicum acidum 15x, Colchicum 15x, Conium 15x, Ferrum metallicum 15x, Gelsemium 15x, Glonoinum 15x, Hyoscyamus 15x, Ipecac. 15x, Iris versicolor 15x, Lycopodium 15x, Nux vom. 15x, Petroleum 15x, Phosphorus 15x, Sepia 15x, Symphoricarpus racemosus 15x, Tabacum 15x, Theridion 15x, Zingiber 15x, Echinacea 3x, Hypericum 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms of the effects or the sensation of movement such as dizziness, discomfort, headache, nausea and disorientation.

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.  

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. 

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
55714-2288-02020-01-31C16284748780-19d75b9d0-bfd7-f424-e053-dadaa90a57ceMotion Sickness
55714-2288-12020-01-31C16284748780-19d75b9d0-bfd7-f424-e053-dadaa90a57ceMotion Sickness
55714-2288-22020-01-31C16284748780-19d75b9d0-bfd7-f424-e053-dadaa90a57ceMotion Sickness

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2288-0Motion Sickness.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-2288-1Motion Sickness29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2288-2Motion Sickness59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2288MOTION SICKNESS (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.]1Legacy NDC, 3 package rows20130110_a4ddf5c9-cb5e-7598-f0d5-7f80d7b6c1d3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V31
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Colchicum Autumnale BulbACTIVE INGREDIENT993QHL78E61
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3711
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GingerACTIVE INGREDIENTC5529G5JPQ1
Hyoscyamus NigerACTIVE INGREDIENT4WRK2153H31
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
IpecacACTIVE INGREDIENT62I3C8233L1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
IronACTIVE INGREDIENTE1UOL152H71
KeroseneACTIVE INGREDIENT1C89KKC04E1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
NitroglycerinACTIVE INGREDIENTG59M7S0WS31
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O1
PhenolACTIVE INGREDIENT339NCG44TV1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Symphoricarpos Albus FruitACTIVE INGREDIENT873JZU3ASZ1
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L1
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
WormwoodACTIVE INGREDIENTF84709P2XV1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Antimony Cation (3+)ACTIVE MOIETY069647RPT51
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Colchicum Autumnale BulbACTIVE MOIETY993QHL78E61
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3711
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GingerACTIVE MOIETYC5529G5JPQ1
Hyoscyamus NigerACTIVE MOIETY4WRK2153H31
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
IpecacACTIVE MOIETY62I3C8233L1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
IronACTIVE MOIETYE1UOL152H71
KeroseneACTIVE MOIETY1C89KKC04E1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
NitroglycerinACTIVE MOIETYG59M7S0WS31
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O1
PhenolACTIVE MOIETY339NCG44TV1
PhosphorusACTIVE MOIETY27YLU75U4W1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Symphoricarpos Albus FruitACTIVE MOIETY873JZU3ASZ1
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L1
Tobacco LeafACTIVE MOIETY6YR2608RSU1
ValerianACTIVE MOIETYJWF5YAW3QW1
WormwoodACTIVE MOIETYF84709P2XV1
AlcoholINACTIVE INGREDIENT3K9958V90M1

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
55714-228855714-2288-1, 55714-2288-2, 55714-2288-0

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WormwoodF84709P2XVACTIB
Aconitum NapellusU0NQ8555JDACTIB
Antimony Potassium TartrateDL6OZ476V3ACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Phenol339NCG44TVACTIB
Colchicum Autumnale Bulb993QHL78E6ACTIB
Conium Maculatum Flowering TopQ28R5GF371ACTIB
IronE1UOL152H7ACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
NitroglycerinG59M7S0WS3ACTIB
Hyoscyamus Niger4WRK2153H3ACTIB
Ipecac62I3C8233LACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Kerosene1C89KKC04EACTIB
Phosphorus27YLU75U4WACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Symphoricarpos Albus Fruit873JZU3ASZACTIB
Tobacco Leaf6YR2608RSUACTIB
Theridion Curassavicum9Z8D3HEM8LACTIB
GingerC5529G5JPQACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Passiflora Incarnata Flowering TopCLF5YFS11OACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

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
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 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
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact 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
507e4e0b-2547-9597-999d-98db06b82d23a4ddf5c9-cb5e-7598-f0d5-7f80d7b6c1d32011-03-01WarningsExact identifier
spl id: 507e4e0b-2547-9597-999d-98db06b82d23
spl set id: a4ddf5c9-cb5e-7598-f0d5-7f80d7b6c1d3

Reported adverse events (FAERS/openFDA)#

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