SPL v2
SPL
SPL Set ID b96238d4-19f7-40a6-94ee-7d14cd878199
Route
ORAL
Published
Effective Date 2014-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Apis Mellifera Arnica Montana Bellis Perennis Bryonia Alba Root Calendula Officinalis Flowering Top Matricaria Recutita Helianthemum Canadense Clematis Vitalba Flower Ferrosoferric Phosphate Histamine Hypericum Perforatum Impatiens Glandulifera Flower Ornithogalum Umbellatum Flowering Top Passiflora Incarnata Flowering Top Phosphorus Prunus Cerasifera Flower Toxicodendron Pubescens Leaf Sulfur Comfrey Root Trifolium Pratense Flower Veratrum Album Root
Inactive Ingredients
Water Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-01

Description

Drug Facts __________________________________________________________________________________________________________ HPUS active ingredients: Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.


Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Indications and Usage

Uses a natural aid for: physical, mental and emotional stress and trauma.

Dosage and Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additonally as needed, up to 6 times per day.
Description

Drug Facts __________________________________________________________________________________________________________ HPUS active ingredients: Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 50565-1
  • Keep out of reach of children
Section 51727-6

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4

Section 55105-1

Uses a natural aid for:

  • physical, mental and emotional stress and trauma.
Section 55106-9

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8

Tamper resistant for your protection . Use only if safety seal is intact.


Structured Label Content

Indications and Usage (34067-9)

Uses a natural aid for: physical, mental and emotional stress and trauma.

Dosage and Administration (34068-7)

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additonally as needed, up to 6 times per day.
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
Section 50565-1 (50565-1)
  • Keep out of reach of children
Section 51727-6 (51727-6)

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses a natural aid for:

  • physical, mental and emotional stress and trauma.
Section 55106-9 (55106-9)

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection . Use only if safety seal is intact.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)