Hypercalm 1738p

Hypercalm 1738p
SPL v1
SPL
SPL Set ID ff604442-4697-e2bb-e053-6394a90a0340
Route
ORAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (6 [hp_X]) Gelsemium Sempervirens Root (15 [hp_X]) Passiflora Incarnata Flowering Top Aconitum Napellus Epinephrine Silver Cation 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 Lycopodium Clavatum Spore Sodium Cation Strychnos Nux-vomica Seed Scutellaria Lateriflora Whole Delphinium Staphisagria Seed Datura Stramonium Theridion Curassavicum Veratrum Viride Root Hops Hypericum Perforatum
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-06-01

Description

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

Indications and Usage

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

Purpose

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


Medication Information

Indications and Usage

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

Purpose

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

Description

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

Package Label

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

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

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.

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

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

Dosage & Administration Section (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 (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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

WARNINGS: Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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