Indications and uses
Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.
Hypercalm-Mental Focus
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2023-06-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:21:33
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, THERIDION CURASSAVICUM, VERATRUM VIRIDE ROOT, HOPS, HYPERICUM PERFORATUM
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS AND 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, 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
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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1738-1 | Hypercalm-Mental Focus | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1738 | HYPERCALM-MENTAL FOCUS (CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE) PELLET [NEWTON LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20230702_ff604442-4697-e2bb-e053-6394a90a0340.zip |
Products#
Every source-derived product name is available through these pages.
- Hypercalm-Mental Focus
- Chamomilla, Echinacea, Hypericum perforatum, Passiflora incarnata, Aconitum napellus, Adrenalinum, Argentum nit., Arsenicum album, Baptisia tinctoria, Chamomilla, Coffea cruda, Cypripedium pubescens, Digitalis purpurea, Gelsemium sempervirens, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Impatiens glandulifera flos, Iodium, Lachesis mutus, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Scutellaria lateriflora, Staphysagria, Stramonium, Theridion, Veratrum viride
- ECHINACEA, UNSPECIFIED
- GELSEMIUM SEMPERVIRENS ROOT
- PASSIFLORA INCARNATA FLOWERING TOP
- ACONITUM NAPELLUS
- EPINEPHRINE
- SILVER NITRATE
- SILVER CATION
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- 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
- SUCROSE
- LYCOPODIUM CLAVATUM SPORE
- SODIUM CHLORIDE
- SODIUM CATION
- STRYCHNOS NUX-VOMICA SEED
- SCUTELLARIA LATERIFLORA WHOLE
- DELPHINIUM STAPHISAGRIA SEED
- DATURA STRAMONIUM
- THERIDION CURASSAVICUM
- VERATRUM VIRIDE ROOT
- HOPS
- HYPERICUM PERFORATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-1738 | 55714-1738-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hypercalm-Mental Focus | CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE | Newton Laboratories, Inc. | ff604442-4697-e2bb-e053-6394a90a0340 | 2023-06-30 | Warnings | 55714-1738-1 55714-1738 55714173801 ff60427d-49e3-b5f4-e053-6294a90ad12c ff604442-4697-e2bb-e053-6394a90a0340 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.