Indications And Usage Section
Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.
Hypercalm-mental Focus Liquid
FDA Label NDC 55714-1538
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Hypercalm-mental Focus (NDC 55714-1538). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one to four times daily or a directed by a health professional. Sensitive person begin with 1 drop 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
USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%
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 (F059 L01)
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