FDA.reportPublic FDA data

Motion Sickness

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:52

Label at a glance#

ProductMotion Sickness
Active ingredientECHINACEA, UNSPECIFIED, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, WORMWOOD, THERIDION CURASSAVICUM, 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, HYPERICUM PERFORATUM, GINGER
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hypericum perforatum 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Absinthium 15x, Aconitum napellus 15x, Antimonium tartaricum 15x, Belladonna 15x, Bryonia 15x, Carbolicum acidum 15x, Colchicum autumnale 15x, Conium maculatum 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Glonoinum 15x, Hyoscyamus niger 15x, Ipecacuanha 15x, Iris versicolor 15x, Lycopodium clavatum 15x, Nux vomica 15x, Petroleum 15x, Phosphorus 15x, Sepia 15x, Symphoricarpus racemosus 15x, Tabacum 15x, Theridion 15x, Zingiber officinale 15x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucros (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2486-1Motion Sickness28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2486MOTION SICKNESS (ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9c5a4018-0231-e92b-e053-2995a90a4016.zip

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
55714-248655714-2486-1

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
SUCROSEC151H8M554IACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
WORMWOODF84709P2XVACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
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
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
GINGERC5529G5JPQACTIB

Source Document#

Source XML

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
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c5a4018-0231-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
ndc (package): 55714-2486-1
ndc (product): 55714-2486
ndc11 (package): 55714248601
spl id: 2d9509a4-abcd-5213-e063-6394a90a827c
spl set id: 9c5a4018-0231-e92b-e053-2995a90a4016

Reported adverse events (FAERS/openFDA)#

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