HYPERACTIVITY - MENTAL FOCUS - epinephrine, citharacanthus spinicrus, aconitum napellus, silver nitrate, arsenic trioxide, baptisia tinctoria, matricaria recutita, cypripedium parvifolum root, digitalis, gelsemium sempervirens root, hops, strychnos ignatii seed, impatiens glandulifera flower, iodine, lachesis muta venom, lycopodium clavatum spore, sodium chloride, strychnos nux-vomica seed, scutellaria lateriflora, delphinium staphisagria seed, datura stramonium, theridion curassavicum, echinacea, unspecified, ginkgo, hypericum perforatum and passiflora incarnata flowering top 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Hyperactivity - Mental Focus  Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Adrenalinum 15x, Tarentula cubensis15x, Aconitum nap. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Chamomilla 10x, Cypripedium 10x, Digitalis 10x, Gelsemium 10x, Humulus 10x, Ignatia 10x, Impatiens glandulifera flos 10x, Iodium 10x, Lachesis 10x, Lycopodium 10x, Nat. mur. 10x, Nux vom.10x, Scutellaria lateriflora 10x, Staphysag. 10x, Stramonium 10x, Theridion 10x, Echinacea 3x, Gingko 3x, Hypericum 3x, Passiflora 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

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

HYPERACTIVITY - MENTAL FOCUS  
adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla, cypripedium, digitalis, gelsemium, humulus, ignatia, impatiens glandulifera flos, iodium, lachesis, lycopodium, nat. mur., nux vom., scutellaria lateriflora, staphysag., stramonium, theridion, echinacea, gingko, hypericum, passiflora liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2316
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (Epinephrine) Epinephrine15 [hp_X]  in 1 mL
Citharacanthus Spinicrus (Citharacanthus Spinicrus) Citharacanthus Spinicrus15 [hp_X]  in 1 mL
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus10 [hp_X]  in 1 mL
Silver Nitrate (Silver Cation) Silver Nitrate10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Baptisia Tinctoria (Baptisia Tinctoria) Baptisia Tinctoria10 [hp_X]  in 1 mL
Matricaria Recutita (Matricaria Recutita) Matricaria Recutita10 [hp_X]  in 1 mL
Cypripedium Parvifolum Root (Cypripedium Parvifolum Root) Cypripedium Parvifolum Root10 [hp_X]  in 1 mL
Digitalis (Digitalis) Digitalis10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root10 [hp_X]  in 1 mL
Hops (Hops) Hops10 [hp_X]  in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed) Strychnos Ignatii Seed10 [hp_X]  in 1 mL
Impatiens Glandulifera Flower (Impatiens Glandulifera Flower) Impatiens Glandulifera Flower10 [hp_X]  in 1 mL
Iodine (Iodine) Iodine10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Sodium Chloride (Chloride Ion) Sodium Chloride10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Scutellaria Lateriflora (Scutellaria Lateriflora) Scutellaria Lateriflora10 [hp_X]  in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed) Delphinium Staphisagria Seed10 [hp_X]  in 1 mL
Datura Stramonium (Datura Stramonium) Datura Stramonium10 [hp_X]  in 1 mL
Theridion Curassavicum (Theridion Curassavicum) Theridion Curassavicum10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Ginkgo (Ginkgo) Ginkgo3 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum3 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (Passiflora Incarnata Flowering Top) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2316-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2316-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2316-0.5 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(55714-2316), API MANUFACTURE(55714-2316)

Revised: 03/2011
Document Id: d1df1f3d-1d2e-a21b-194b-50d5902b9f3c
Set id: 88d1180c-88db-044d-0c77-53aaad7a0a61
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.