HYPERCALM - MENTAL FOCUS- adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla, coffea cruda, cypripedium, digitalis, gelsemium, humulus, hyoscyamus, ignatia, impatiens glandulifera flos, iodium, lachesis, lycopodium, nat. mur., nux vom., scutellaria lateriflora, staphysag., stramonium, theridion, veratrum viride, echinacea, hypericum, passiflora liquid

Hypercalm - Mental Focus by

Drug Labeling and Warnings

Hypercalm - Mental Focus by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE SECTION

Hypercalm - Mental Focus  Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

DOSAGE & ADMINISTRATION SECTION

ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 cubensis 15x, Aconitum nap. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Chamomilla 10x, Coffea cruda 10x, Cypripedium 10x, Digitalis 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 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, Veratrum viride 10x, Chamomilla 3x, Echinacea 3x, Hypericum 3x, Passiflora 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

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, GA30012
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

INGREDIENTS AND APPEARANCE

HYPERCALM - MENTAL FOCUS  
adrenalinum, tarentula cubensis, aconitum nap., arg. nit., arsenicum alb., baptisia, chamomilla, coffea cruda, cypripedium, digitalis, gelsemium, humulus, hyoscyamus, ignatia, impatiens glandulifera flos, iodium, lachesis, lycopodium, nat. mur., nux vom., scutellaria lateriflora, staphysag., stramonium, theridion, veratrum viride, echinacea, hypericum, passiflora liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-1514
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)	Epinephrine	15 [hp_X]  in 1 mL
Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823)	Citharacanthus Spinicrus	15 [hp_X]  in 1 mL
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	10 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	10 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	10 [hp_X]  in 1 mL
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y)	Baptisia Tinctoria	10 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	10 [hp_X]  in 1 mL
Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72)	Arabica Coffee Bean	10 [hp_X]  in 1 mL
Cypripedium Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA)	Cypripedium Parvifolum Root	10 [hp_X]  in 1 mL
Digitalis (UNII: F1T8QT9U8B) (Digitalis - UNII:F1T8QT9U8B)	Digitalis	10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	10 [hp_X]  in 1 mL
Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83)	Hops	10 [hp_X]  in 1 mL
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3)	Hyoscyamus Niger	10 [hp_X]  in 1 mL
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K)	Strychnos Ignatii Seed	10 [hp_X]  in 1 mL
Impatiens Glandulifera Flower (UNII: AJU5O1A5ZV) (Impatiens Glandulifera Flower - UNII:AJU5O1A5ZV)	Impatiens Glandulifera Flower	10 [hp_X]  in 1 mL
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	10 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I)	Lachesis Muta Venom	10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	10 [hp_X]  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698)	Sodium Chloride	10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	10 [hp_X]  in 1 mL
Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC)	Scutellaria Lateriflora	10 [hp_X]  in 1 mL
Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV)	Delphinium Staphisagria Seed	10 [hp_X]  in 1 mL
Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3)	Datura Stramonium	10 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L)	Theridion Curassavicum	10 [hp_X]  in 1 mL
Veratrum Viride Root (UNII: 197B3Q7T5Q) (Veratrum Viride Root - UNII:197B3Q7T5Q)	Veratrum Viride Root	10 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	3 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O)	Passiflora Incarnata Flowering Top	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-1514-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC: 55714-1514-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC: 55714-1514-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-1514)