FDA.reportPublic FDA data

Hyperactivity-Mental Focus

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:46:26

Label at a glance#

ProductHyperactivity-Mental Focus
Active ingredientSCUTELLARIA LATERIFLORA WHOLE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM, THERIDION CURASSAVICUM, ECHINACEA, UNSPECIFIED, GINKGO, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA FLOWERING TOP, CITHARACANTHUS SPINICRUS, EPINEPHRINE, ACONITUM NAPELLUS, SILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, MATRICARIA CHAMOMILLA, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS 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
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Gingko biloba 6x, Hypericum perforatum 6x, Passiflora incarnata 6x, Aconitum napellus 15x, Adrenalinum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Chamomilla 15x, Cypripedium pubescens 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Ignatia amara 15x, Impatiens glandulifera flos 15x, Iodium 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Nux vomica 15x, Scutellaria lateriflora 15x, Staphysagria 15x, Stramonium 15x, Tarentula cubensis 15x, Theridion 15x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-246255714-2462-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GINKGO19FUJ2C58TACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
CITHARACANTHUS SPINICRUS3Y5X6RT823ACTIB
EPINEPHRINEYKH834O4BHACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT21Y9GZ1LZAACTIB
DIGITALISF1T8QT9U8BACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HOPS01G73H6H83ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
132b5c81-4bad-bc21-e063-6394a90a6fff9c0c93d2-9976-13e3-e053-2a95a90aa4852024-03-08WarningsExact identifier
spl set id: 9c0c93d2-9976-13e3-e053-2a95a90aa485

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.