Label: STRESS CONTROL- aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, clematis vitalba, flos, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, rhus tox, sulphur, symphytum officinale, veratrum album liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-5852-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 17, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
HPUS Active Ingredients
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.
Aconitum napellus
Apis mellifica
Arnica montana
Arsenicum album
Belladonna
Bellis perennis
Bryonia
Calendula officinalis
Chamomilla
Clematis erecta
Clematis vitalba, flos
Ferrum phosphoricum
Histaminum hydrochloricum
Hypericum perforatum
Ignatia amara
Impatiens glandulifera, flos
Ornithogalum umbellatum, flos
Passiflora incarnata
Phosphorus
Prunus cerasifera, flos
Rhus tox
Sulphur
Symphytum officinale
Veratrum album -
INACTIVE INGREDIENT
Inactive ingredients
Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides). -
INDICATIONS & USAGE
Uses temporarily relieves symptoms due to mental,
emotional or physical stress: █ nervous tension █ body aches
█ restlessness █ irritability █ oversensitivity █ sleeplessness
† as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested. - WARNINGS
- DOSAGE & ADMINISTRATION
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PURPOSE
Active ingredients .....................................................Purpose †
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.
Aconitum napellus..................................................fears, tension
Apis mellifica ................................................apathy, indifference
Arnica montana .....................................................oversensitivity
Arsenicum album.................... tension, restlessness, exhaustion
Belladonna .................................agitation, excited mental states
Bellis perennis..............................sore muscles, bruises, aching
Bryonia ..........................................................................irritability
Calendula officinalis ................................................nervousness
Chamomilla ...............................................weepiness, sensitivity
Clematis erecta ................................indifference, sleeplessness
Clematis vitalba, flos ............................................... lack of focus
Ferrum phosphoricum ................................... poor concentration
Histaminum hydrochloricum...........................sensitivity to trifles
Hypericum perforatum...............................................melancholy
Ignatia amara .....................................................fear, impatience
Impatiens glandulifera, flos.........................................impatience
Ornithogalum umbellatum, flos.....................................low spirits
Passiflora incarnata...................................worry and exhaustion
Phosphorus ................................................................fearfulness
Prunus cerasifera, flos....................................................agitation
Rhus tox ...................................................restlessness, sadness
Sulphur..................................................weak memory, irritability
Symphytum officinale ............................ headaches, body aches
Veratrum album............................................................sensitivity
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STRESS CONTROL
aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, clematis vitalba, flos, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, rhus tox, sulphur, symphytum officinale, veratrum album liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5852 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 10 [hp_X] in 59 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 59 mL ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 59 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 10 [hp_X] in 59 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 10 [hp_X] in 59 mL BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 10 [hp_X] in 59 mL CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER 10 [hp_X] in 59 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] in 59 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] in 59 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 10 [hp_X] in 59 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 10 [hp_X] in 59 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 59 mL CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP 10 [hp_X] in 59 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 10 [hp_X] in 59 mL ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP 10 [hp_X] in 59 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER 10 [hp_X] in 59 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 59 mL PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 10 [hp_X] in 59 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 10 [hp_X] in 59 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 59 mL VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) REBAUDIOSIDE A (UNII: B3FUD0528F) WATER (UNII: 059QF0KO0R) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) CARYA OVATA BARK (UNII: X765CF609L) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-5852-2 1 in 1 CARTON 02/01/2019 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/01/2019 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-5852) , manufacture(57955-5852)