Hyperactivity-Mental Focus

Manufacturer
Newton Laboratories, Inc.
Effective date
2023-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:21:33

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, 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 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop 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, 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: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2579-1Hyperactivity-Mental Focus30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2579HYPERACTIVITY-MENTAL FOCUS (ADRENALINUM, 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.]1Current NDC, 1 package rows20230703_febf610e-e08a-4797-e053-6294a90a3eb5.zip

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
55714-257955714-2579-1

Ingredients#

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

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

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
Hyperactivity-Mental FocusADRENALINUM, 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, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
ndc (package): 55714-2579-1
ndc (product): 55714-2579
ndc11 (package): 55714257901
spl id: febf5942-5eca-f19b-e053-6294a90a32c1
spl set id: febf610e-e08a-4797-e053-6294a90a3eb5

Reported adverse events (FAERS/openFDA)#

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