HYPERACTIVITY - MENTAL FOCUS - adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla,

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH), Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823), Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD), Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A), Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV), Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y), Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutit
Available from:
Newton Laboratories, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hyperactivity - Mental Focus  Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity. Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.
Authorization status:
unapproved homeopathic
Authorization number:
55714-2316-0, 55714-2316-1, 55714-2316-2

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

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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Hyperactivity - Mental Focus

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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-2316

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Epinephrine (UNII: YKH8 34O4BH) (Epinephrine - UNII:YKH8 34O4BH)

Epine phrine

15 [hp_X]

in 1 mL

Citha ra ca nthus Spinicrus (UNII: 3Y5X6 RT8 23) (Citharacanthus Spinicrus -

UNII:3Y5X6 RT8 23)

Citharacanthus Spinicrus

15 [hp_X]

in 1 mL

Aco nitum Na pellus (UNII: U0 NQ8 555JD) (Aco nitum Napellus - UNII:U0 NQ8 555JD)

Aco nitum Napellus

10 [hp_X]

in 1 mL

Silver Nitra te (UNII: 9 5IT3W8 JZE) (Silver Catio n - UNII:57N7B0 K9 0 A)

Silver Nitrate

10 [hp_X]

in 1 mL

Arsenic Trio xide (UNII: S7V9 2P6 7HO) (Arsenic Catio n (3+) - UNII:C9 6 6 13F5AV)

Arsenic Trio xide

10 [hp_X]

in 1 mL

Ba ptisia Tincto ria (UNII: 5K1UO28 8 8 Y) (Baptisia Tincto ria - UNII:5K1UO28 8 8 Y)

Baptisia Tincto ria

10 [hp_X]

in 1 mL

Ma trica ria Recutita (UNII: G0 R4UBI2ZZ) (Matricaria Recutita - UNII:G0 R4UBI2ZZ)

Matricaria Recutita

10 [hp_X]

in 1 mL

Cypripedium Pa rvifo lum Ro o t (UNII: 21Y9 GZ1LZA) (Cypripedium Parvifo lum Ro o t -

UNII:21Y9 GZ1LZA)

Cypripedium Parvifo lum

Ro o t

10 [hp_X]

in 1 mL

Dig ita lis (UNII: F1T8 QT9 U8 B) (Digitalis - UNII:F1T8 QT9 U8 B)

Digita lis

10 [hp_X]

in 1 mL

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

10 [hp_X]

in 1 mL

Ho ps (UNII: 0 1G73H6 H8 3) (Ho ps - UNII:0 1G73H6 H8 3)

Ho ps

10 [hp_X]

in 1 mL

Strychno s Ig na tii Seed (UNII: 1NM3M248 7K) (Strychno s Ignatii Seed -

UNII:1NM3M248 7K)

Strychno s Ignatii Seed

10 [hp_X]

in 1 mL

Impa tiens Gla ndulifera Flo wer (UNII: AJU5O1A5ZV) (Impatiens Glandulifera Flo wer -

UNII:AJU5O1A5ZV)

Impatiens Glandulifera

Flo we r

10 [hp_X]

in 1 mL

Io dine (UNII: 9 6 79 TC0 7X4) (Io dine - UNII:9 6 79 TC0 7X4)

Io dine

10 [hp_X]

in 1 mL

La chesis Muta Veno m (UNII: VSW71SS0 7I) (Lachesis Muta Veno m - UNII:VSW71SS0 7I)

Lachesis Muta Veno m

10 [hp_X]

in 1 mL

Lyco po dium Cla va tum Spo re (UNII: C8 8 X29 Y479 ) (Lyco po dium Clavatum Spo re -

UNII:C8 8 X29 Y479 )

Lyco po dium Clavatum

Spo re

10 [hp_X]

in 1 mL

So dium Chlo ride (UNII: 451W47IQ8 X) (Chlo ride Io n - UNII:Q32ZN48 6 9 8 )

So dium Chlo ride

10 [hp_X]

in 1 mL

Strychno s Nux-vo mica Seed (UNII: 26 9 XH139 19 ) (Strychno s Nux-vo mica Seed -

UNII:26 9 XH139 19 )

Strychno s Nux-vo mica

Se e d

10 [hp_X]

in 1 mL

Scutella ria La teriflo ra (UNII: 7BP4DH5PDC) (Scutellaria Lateriflo ra - UNII:7BP4DH5PDC)

Scutellaria Lateriflo ra

10 [hp_X]

in 1 mL

Delphinium Sta phisa g ria Seed (UNII: 0 0 543AP1JV) (Delphinium Staphisagria Seed -

UNII:0 0 543AP1JV)

Delphinium Staphisagria

Se e d

10 [hp_X]

in 1 mL

Da tura Stra mo nium (UNII: G6 W4F0 V8 Z3) (Datura Stramo nium - UNII:G6 W4F0 V8 Z3)

Datura Stramo nium

10 [hp_X]

in 1 mL

Theridio n Cura ssa vicum (UNII: 9 Z8 D3HEM8 L) (Theridio n Curassavicum -

UNII:9 Z8 D3HEM8 L)

Theridio n Curassavicum

10 [hp_X]

in 1 mL

Echina cea , Unspecified (UNII: 4N9 P6 CC1DX) (Echinacea, Unspecified -

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

3 [hp_X]

in 1 mL

Ginkg o (UNII: 19 FUJ2C58 T) (Ginkgo - UNII:19 FUJ2C58 T)

Ginkgo

3 [hp_X]

in 1 mL

Hypericum Perfo ra tum (UNII: XK4IUX8 MNB) (Hypericum Perfo ratum -

UNII:XK4IUX8 MNB)

Hypericum Perfo ratum

3 [hp_X]

in 1 mL

Pa ssiflo ra Inca rna ta Flo wering To p (UNII: CLF5YFS11O) (Passiflo ra Incarnata Flo wering

To p - UNII:CLF5YFS11O)

Passiflo ra Incarnata

Flo wering To p

3 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-2316 -1

29 .57 mL in 1 BOTTLE, GLASS

2

NDC:55714-2316 -2

59 .14 mL in 1 BOTTLE, GLASS

3

NDC:55714-2316 -0

.5 mL in 1 BOTTLE, GLASS

Newton Laboratories, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/0 1/20 11

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE(55714-2316 )

Revised: 3/2011

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