Label: STRESS CONTROL / CONTROLE DU STRESS- aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, passiflora incarnata, phosphorus, rhus toxicodendron, sulphur, symphytum officinale, veratrum album liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-1805-2 - 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 August 21, 2014
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ACTIVE INGREDIENT
Medicinal ingredients/Ingrédients médicinaux: Aconitum napellus 10X, 30X, 1LM, Apis mellifica 10X, 30X, 1LM, Arnica montana 10X, 30X, 1LM, Arsenicum album 10X, 30X, 1LM, Belladonna 10X, 30X, 1LM, Bellis perennis 10X, 30X, 1LM, Bryonia 10X, 30X, 1LM, Calendula officinalis 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Clematis erecta 10X, 30X, 1LM, Ferrum phosphoricum 10X, 30X, 1LM, Histaminum hydrochloricum 10X, 30X, 1LM, Hypericum perforatum 10X, 30X, 1LM, Ignatia amara 10X, 30X, 1LM, Passiflora incarnata 10X, 30X, 1LM, Phosphorus 10X, 30X, 1LM, Rhus toxicodendron 10X, 30X, 1LM, Sulphur 10X, 30X, 1LM, Symphytum officinale 10X, 30X, 1LM, Veratrum album 10X, 30X, 1LM. Ingredient source information sur la source des ingrédients: canada.kingbio.com
- INACTIVE INGREDIENT
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PURPOSE
Indications: A homeopathic remedy for the temporary relief of the following symptoms due to mental, emotional or physical stress: tension, nervousness, exhaustion, restlessness, apathy, irritability, oversensitivity, soreness sleeplessness, melancholy, fearfulness and impatience.
Indications: un remde homéopathique pour le soulagement temporaire des symptômes suivants dus au stress mental, émotionnel ou physique: tension, nervosité, épuisement, agitation, apathie, irritabilité, hypersensibilité, endolorissement, insomnie, mélancolie, appréhension et impatience.
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Indications: A homeopathic remedy for the temporary relief of the following symptoms due to mental, emotional or physical stress:
- tension
- nervousness
- exhaustion
- restlessness
- apathy
- irritability
- oversensitivity
- soreness
- sleeplessness
- melancholy
- fearfulness
- impatience
Indications: un remède homéopathique pour le soulagement temporaire des symptômes suivants dus au stress mental, émotionnel ou physique:
- tension
- nervosité
- épuisement
- agitation
- apathie
- irritabilité
- hypersensibilité
- endolorissement
- insomnie
- mélancolie
- appréhension et impatience
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WARNINGS
Cautions and Warnings: Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner prior to use if you are pregnant or breastfeeding.
Précaution(s) et mise(s) en garde: Consulter un praticien de soins de santé si les symptômes persistent ou s'aggravent. Consulter un praticien de soins de santé avant d'en faire l'usage si vous êtes enceinte ou allaitante.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STRESS CONTROL / CONTROLE DU STRESS
aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, passiflora incarnata, phosphorus, rhus toxicodendron, sulphur, symphytum officinale, veratrum album liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-1805 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 10 [hp_X] in 59 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 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 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 RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 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 HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 59 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 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 PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 59 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-1805-2 1 in 1 CARTON 1 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/05/2014 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-1805)