Motion Sickness

Motion Sickness
SPL v1
SPL
SPL Set ID a4ddf5c9-cb5e-7598-f0d5-7f80d7b6c1d3
Route
ORAL
Published
Effective Date 2012-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Wormwood (15 [hp_X]) Aconitum Napellus (3 [hp_X]) Antimony Cation (3+) 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
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256 

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%. 

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Otc Purpose Section (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 INGREDIENT SECTION)

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

Indications & Usage Section (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 (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 (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 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. 

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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