KIDS STRESS AND ANXIETY (ACONITUM NAPELLUS, AETHUSA CYNAPIUM, ALFALFA, AURUM METALLICUM, AVENA SATIVA, BARYTA CARBONICA, CHAMOMILLA, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHOR

KIDS STRESS AND ANXIETY (ACONITUM NAPELLUS, AETHUSA CYNAPIUM, ALFALFA, AURUM METALLICUM, AVENA SATIVA, BARYTA CARBONICA, CHAMOMILLA, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHOR
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NDC 57955-0423-2
Set ID e6c65ffe-d225-4f58-9f9e-e0a656ed16f8
Category HUMAN OTC DRUG LABEL
Packager King Bio Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: ​Aconitum napellus, Aethusa cynapium, Alfalfa, Aurum metallicum, Avena sativa, Baryta carbonica, Chamomilla, Ignatia amara, Impatiens glandulifera, flos, Kali phosphoricum, Laurocerasus, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Staphysagria, Stramonium. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

  • INDICATIONS & USAGE

    Uses ​for temporary relief of symptoms:

    • stress
    • minor anxiety
    • fear
    • irritability
    • nervousness
    • agitation
    • mood swings
    • worry
    • restlessness
    • nervous stomach
    • oversensitivity
    • whining
    • emotional overexcitement
    • performance anxiety
    • anger
    • difficulty concentrating
    • inconsolable
    • overwhelmed

    as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

  • WARNINGS

    Warnings

    • Stop use and consult a doctor if symptoms worsen or persist for more than 7 days (3 days for children under 2).
    • Keep out of reach of children.
    • As with any drug, consult a doctor before use if pregnant or nursing.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • 2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved.
    • 6 to 12 Years: 2 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.
    • 12 years & older: 3 sprays, every 15 minutes, up to 8 doses, then hourly until relieved.
  • OTHER SAFETY INFORMATION

    Other information

    This product is intended to complement, not replace, standard medical care. • Tamper resistant for your protection. Use only if safety seal is intact.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

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

  • PURPOSE

    Drug Facts_________________________________________________________________________________________________

    HPUS* active ingredients                                      Purpose†

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Aconitum napellus........................................emotional overexcitement

    Aethusa cynapium.....................................................inability to focus

    Alfalfa..............................................................gloominess, irritability

    Aurum metallicum.................................overstimulated, noise-sensitive

    Avena sativa....................................................difficulty concentrating

    Baryta carbonica........................................confusion, loss of confidence

    Chamomilla.......................................oversensitivity, whining, agitation

    Ignatia amara....................................................mood changes, worry

    Impatiens glandulifera, flos.............................overwhelmed, impatient

    Kali phosphoricum.............................................startles easily, anxiety

    Laurocerasus...................................................anger if misunderstood

    Natrum phosphoricum.................................................nighttime fears

    Passiflora incarnata..................................................nervous stomach

    Phosphorus..............................................performance anxiety, stress

    Prunus cerasifera, flos..................................anxiousness, restlessness

    Staphysagria.....................................................irritable nervousness

    Stramonium..............................................mood swings, inconsolable

    *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS STRESS AND ANXIETY 
    aconitum napellus, aethusa cynapium, alfalfa, aurum metallicum, avena sativa, baryta carbonica, chamomilla, ignatia amara, impatiens glandulifera, flos, kali phosphoricum, laurocerasus, natrum phosphoricum, passiflora incarnata, phosphorus, prunus cerasifera, flos, staphysagria, stramonium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0423
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM10 [hp_X]  in 59 mL
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA10 [hp_X]  in 59 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD10 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER10 [hp_X]  in 59 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
    PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF10 [hp_X]  in 59 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER10 [hp_X]  in 59 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 59 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0423-21 in 1 CARTON09/01/2016
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2016
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0423)

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