FDA.reportPublic FDA data

Hypercalm-Mental Focus

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:42:03

Label at a glance#

ProductHypercalm-Mental Focus
Active ingredientECHINACEA, UNSPECIFIED, GELSEMIUM SEMPERVIRENS ROOT, PASSIFLORA INCARNATA FLOWERING TOP, ACONITUM NAPELLUS, EPINEPHRINE, SILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, DIGITALIS, HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, IMPATIENS GLANDULIFERA FLOWER, IODINE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SCUTELLARIA LATERIFLORA WHOLE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM, CITHARACANTHUS SPINICRUS, THERIDION CURASSAVICUM, VERATRUM VIRIDE ROOT, HOPS, HYPERICUM PERFORATUM
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Hypericum perforatum 6x, Passiflora incarnata 6x, Aconitum napellus 15x, Adrenalinum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Chamomilla 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Hyoscyamus niger 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, Veratrum viride 15x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

WARNINGS: 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 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-173555714-1735-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
EPINEPHRINEYKH834O4BHACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT21Y9GZ1LZAACTIB
DIGITALISF1T8QT9U8BACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IMPATIENS GLANDULIFERA FLOWERAJU5O1A5ZVACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SUCROSEC151H8M554IACT
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
CITHARACANTHUS SPINICRUS3Y5X6RT823ACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
VERATRUM VIRIDE ROOT197B3Q7T5QACTIB
HOPS01G73H6H83ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB

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
0b27559c-882c-b387-e063-6394a90a0a749db05bc6-fccf-6738-e053-2995a90a8ffb2023-11-27WarningsExact identifier
spl set id: 9db05bc6-fccf-6738-e053-2995a90a8ffb

Reported adverse events (FAERS/openFDA)#

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