MOTION 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.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Motion Sickness

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

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

MOTION 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2288
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Wormwood (UNII: F84709P2XV) (Wormwood - UNII:F84709P2XV) Wormwood15 [hp_X]  in 1 mL
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 mL
Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Potassium Tartrate15 [hp_X]  in 1 mL
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol15 [hp_X]  in 1 mL
Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb15 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top15 [hp_X]  in 1 mL
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron15 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin15 [hp_X]  in 1 mL
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger15 [hp_X]  in 1 mL
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac15 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene15 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Symphoricarpos Albus Fruit (UNII: 873JZU3ASZ) (Symphoricarpos Albus Fruit - UNII:873JZU3ASZ) Symphoricarpos Albus Fruit15 [hp_X]  in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum3 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2288-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2288-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2288-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2288)

Revised: 3/2011
Document Id: 507e4e0b-2547-9597-999d-98db06b82d23
Set id: a4ddf5c9-cb5e-7598-f0d5-7f80d7b6c1d3
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.