DIZZINESS - 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.

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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Dizziness - Vertigo

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

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

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

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

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

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

Keep out of reach of children.

PACKAGE LABEL

Package Label

DIZZINESS - 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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4508
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Wormwood (UNII: F84709P2XV) (Wormwood - UNII:F84709P2XV) Wormwood20 [hp_X]  in 1 mL
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus20 [hp_X]  in 1 mL
Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Potassium Tartrate20 [hp_X]  in 1 mL
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna20 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 mL
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol20 [hp_X]  in 1 mL
Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb20 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top20 [hp_X]  in 1 mL
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Nitroglycerin (UNII: G59M7S0WS3) (Nitroglycerin - UNII:G59M7S0WS3) Nitroglycerin20 [hp_X]  in 1 mL
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger20 [hp_X]  in 1 mL
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac20 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root20 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore20 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed20 [hp_X]  in 1 mL
Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene20 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice20 [hp_X]  in 1 mL
Symphoricarpos Albus Fruit (UNII: 873JZU3ASZ) (Symphoricarpos Albus Fruit - UNII:873JZU3ASZ) Symphoricarpos Albus Fruit20 [hp_X]  in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf20 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum20 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger20 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum8 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top8 [hp_X]  in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian8 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4508-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4508-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4508)

Revised: 6/2011
Document Id: 24f89fb0-b485-42ba-f060-264f60505616
Set id: f76d4389-dd27-ca13-dc55-e41dcfa2f72b
Version: 2
Effective Time: 20110601
 
Newton Laboratories, Inc.