Hyperactivity 4852l

Hyperactivity 4852l
SPL v1
SPL
SPL Set ID fed03a1c-0ea8-1f8e-e053-6394a90a04c0
Route
ORAL
Published
Effective Date 2023-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (20 [hp_X]) Aconitum Napellus (11 [hp_X]) Silver Cation Arsenic Cation (3+) 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 Chloride Ion Strychnos Nux-vomica Seed Scutellaria Lateriflora Whole Delphinium Staphisagria Seed Datura Stramonium Theridion Curassavicum Echinacea, Unspecified Ginkgo Hypericum Perforatum Passiflora Incarnata Flowering Top
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-03

Description

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

Purpose

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.


Medication Information

Purpose

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

Description

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

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 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%.

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.

Otc Active Ingredient Section

Equal parts of Echinacea 11x, Gingko biloba 11x, Hypericum perforatum 11x, Passiflora incarnata 11x, Aconitum napellus 20x, Adrenalinum 20x, Argentum nitricum 20x, Arsenicum album 20x, Baptisia tinctoria 20x, Chamomilla 20x, Cypripedium pubescens 20x, Digitalis purpurea 20x, Gelsemium sempervirens 20x, Humulus lupulus 20x, Ignatia amara 20x, Impatiens glandulifera flos 20x, Iodium 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Natrum muriaticum 20x, Nux vomica 20x, Scutellaria lateriflora 20x, Staphysagria 20x, Stramonium 20x, Theridion 20x.

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.


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 lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as lack of focus, anxiety, anger, impulsiveness, restlessness and sensitivity.

Dosage & Administration Section (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.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 11x, Gingko biloba 11x, Hypericum perforatum 11x, Passiflora incarnata 11x, Aconitum napellus 20x, Adrenalinum 20x, Argentum nitricum 20x, Arsenicum album 20x, Baptisia tinctoria 20x, Chamomilla 20x, Cypripedium pubescens 20x, Digitalis purpurea 20x, Gelsemium sempervirens 20x, Humulus lupulus 20x, Ignatia amara 20x, Impatiens glandulifera flos 20x, Iodium 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Natrum muriaticum 20x, Nux vomica 20x, Scutellaria lateriflora 20x, Staphysagria 20x, Stramonium 20x, Theridion 20x.

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)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)