Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 1e677618-1367-43de-ba2b-83be8e633e30
Route
ORAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Apis Mellifera Arnica Montana Arsenic Cation (3+) Atropa Belladonna Bellis Perennis Bryonia Alba Root Calendula Officinalis Flowering Top Matricaria Recutita Helianthemum Canadense Clematis Recta Flowering Top Ferrum Phosphoricum Histamine Hypericum Perforatum Strychnos Ignatii Seed Impatiens Glandulifera Flower Ornithogalum Umbellatum Passiflora Incarnata Flower Phosphorus Prunus Cerasifera Flower Toxicodendron Pubescens Leaf Sulfur Comfrey Root Veratrum Album Root
Inactive Ingredients
Water Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-11-07

Description

Aconitum napellus, Hypericum perforatum HPUS Apis mellifica, Arsenicum album HPUS Arnica montana, Calendula officinalis, Ferrum phosphoricum, Histaminum hydrochloricum, Ignatia amara HPUS Belladonna, Bellis perennis, Chamomilla HPUS Bryonia, Passiflora incarnata, Sulphur, Symphytum officinale, Veratrum album HPUS Cistus canadensis HPUS Clematis erecta, Phosphorus HPUS Impatiens glandulifera, flos, Prunus cerasifera, flos HPUS Ornithogalum umbellatum, flos HPUS Rhus toxicodendron HPUS Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Aconitum napellus, Hypericum perforatum HPUS….......................................Anxiety Apis mellifica, Arsenicum album HPUS.....Fearfulness Arnica montana, Calendula officinalis, Ferrum phosphoricum, Histaminum hydrochloricum, Ignatia amara HPUS…...........................Nervousness Belladonna, Bellis perennis, Chamomilla HPUS.............................Restless Sleep Bryonia, Passiflora incarnata, Sulphur, Symphytum officinale, Veratrum album HPUS............................Headaches Cistus canadensis HPUS.......................Sleeplessness Clematis erecta, Phosphorus HPUS....Oversensitivity Impatiens glandulifera, flos, Prunus cerasifera, flos HPUS..........Stressed out by situation Ornithogalum umbellatum, flos HPUS.....Depression Rhus toxicodendron HPUS………….…….Apprehension


Medication Information

Purpose

Aconitum napellus, Hypericum

perforatum HPUS….......................................Anxiety





Apis mellifica, Arsenicum album HPUS.....Fearfulness





Arnica montana, Calendula

officinalis, Ferrum phosphoricum,



Histaminum hydrochloricum,

Ignatia amara HPUS…...........................Nervousness





Belladonna, Bellis perennis,

Chamomilla HPUS.............................Restless Sleep





Bryonia, Passiflora incarnata,

Sulphur, Symphytum officinale,

Veratrum album HPUS............................Headaches



Cistus canadensis HPUS.......................Sleeplessness



Clematis erecta, Phosphorus HPUS....Oversensitivity



Impatiens glandulifera, flos,

Prunus cerasifera, flos HPUS..........Stressed out by situation



Ornithogalum umbellatum, flos HPUS.....Depression



Rhus toxicodendron HPUS………….…….Apprehension



Description

  • 30-day supply
  • dropper included
  • Stressivin is made without alcohol or sugar. No gluten added.



Mftd for: HelloLife, LLC

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.stressivin.com

Uses

to temporarily relieve symptoms commonly associated with stress such as:

•    nervous tension

•    over-sensitivity

•    anxiety

•    fearfulness



Section 50565-1



Keep out of the reach of children.

Warnings



Directions

Dispense Stressivin directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink. Safe for ages 2 and up.



Dosage By Weight

30-50 lbs                   1/2 mL

(13.6-22.6 kg)             twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information



•    do not use if tamper seal is broken

•    store in a cool, dry place

•    product must not come in contact with metal

•    do not store next to electrical devices or appliances

Inactive Ingredients



citric acid, potassium sorbate, purified ionized mineral water

Questions Or Comments?

You can email us at [email protected] or call us toll-free at

 1.800.875.0850. Monday through Friday, 9am-5pm ET



Principal Display Panel

NDC 49726-019-02

Stressivin TM



Stress Relief



To temporarily relieve symptoms commonly associated with stress such as:

•    nervous tension

•    over-sensitivity

•    anxiety

•    fearfulness



2 fl oz (59 mL)

Homeopathic (OTC) Medicine

When Using This Product

use only as directed.

Ask A Doctor Before Use If



•    you are taking any other medications

•    you have a medical condition

Stop Use and Ask A Doctor If

 symptoms persist or worsen.  

Active Ingredients (per Dose)
Aconitum napellus, Hypericum perforatum HPUS





Apis mellifica, Arsenicum album HPUS





Arnica montana, Calendula



officinalis, Ferrum phosphoricum,

Histaminum hydrochloricum,

Ignatia amara HPUS



Belladonna, Bellis perennis,

Chamomilla HPUS



Bryonia, Passiflora incarnata,

Sulphur, Symphytum officinale,

Veratrum album HPUS



Cistus canadensis HPUS



Clematis erecta, Phosphorus HPUS





Impatiens glandulifera, flos,

Prunus cerasifera, flos HPUS



Ornithogalum umbellatum, flos HPUS



Rhus toxicodendron HPUS







Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies.

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Product indications are based on Homeopathic Materia Medica.


If Pregnant Or Breast Feeding,

ask a health professional before use.




Structured Label Content

Uses

to temporarily relieve symptoms commonly associated with stress such as:

•    nervous tension

•    over-sensitivity

•    anxiety

•    fearfulness



Description (34089-3)

  • 30-day supply
  • dropper included
  • Stressivin is made without alcohol or sugar. No gluten added.



Mftd for: HelloLife, LLC

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.stressivin.com

Section 50565-1 (50565-1)



Keep out of the reach of children.

Purpose

Aconitum napellus, Hypericum

perforatum HPUS….......................................Anxiety





Apis mellifica, Arsenicum album HPUS.....Fearfulness





Arnica montana, Calendula

officinalis, Ferrum phosphoricum,



Histaminum hydrochloricum,

Ignatia amara HPUS…...........................Nervousness





Belladonna, Bellis perennis,

Chamomilla HPUS.............................Restless Sleep





Bryonia, Passiflora incarnata,

Sulphur, Symphytum officinale,

Veratrum album HPUS............................Headaches



Cistus canadensis HPUS.......................Sleeplessness



Clematis erecta, Phosphorus HPUS....Oversensitivity



Impatiens glandulifera, flos,

Prunus cerasifera, flos HPUS..........Stressed out by situation



Ornithogalum umbellatum, flos HPUS.....Depression



Rhus toxicodendron HPUS………….…….Apprehension



Warnings



Directions

Dispense Stressivin directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink. Safe for ages 2 and up.



Dosage By Weight (DOSAGE BY WEIGHT)

30-50 lbs                   1/2 mL

(13.6-22.6 kg)             twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information (Other information)



•    do not use if tamper seal is broken

•    store in a cool, dry place

•    product must not come in contact with metal

•    do not store next to electrical devices or appliances

Inactive Ingredients (Inactive ingredients)



citric acid, potassium sorbate, purified ionized mineral water

Questions Or Comments? (Questions or comments?)

You can email us at [email protected] or call us toll-free at

 1.800.875.0850. Monday through Friday, 9am-5pm ET



Principal Display Panel

NDC 49726-019-02

Stressivin TM



Stress Relief



To temporarily relieve symptoms commonly associated with stress such as:

•    nervous tension

•    over-sensitivity

•    anxiety

•    fearfulness



2 fl oz (59 mL)

Homeopathic (OTC) Medicine

When Using This Product (When using this product)

use only as directed.

Ask A Doctor Before Use If (Ask a doctor before use if)



•    you are taking any other medications

•    you have a medical condition

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

 symptoms persist or worsen.  

Active Ingredients (per Dose) (Active Ingredients (per dose))
Aconitum napellus, Hypericum perforatum HPUS





Apis mellifica, Arsenicum album HPUS





Arnica montana, Calendula



officinalis, Ferrum phosphoricum,

Histaminum hydrochloricum,

Ignatia amara HPUS



Belladonna, Bellis perennis,

Chamomilla HPUS



Bryonia, Passiflora incarnata,

Sulphur, Symphytum officinale,

Veratrum album HPUS



Cistus canadensis HPUS



Clematis erecta, Phosphorus HPUS





Impatiens glandulifera, flos,

Prunus cerasifera, flos HPUS



Ornithogalum umbellatum, flos HPUS



Rhus toxicodendron HPUS







Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies.

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Product indications are based on Homeopathic Materia Medica.


If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)