Label: FEARS AND NIGHTMARES- aconitum napellus, aesculus carnea, flos, allium sativum, aurum bromatum, calcarea carbonica, chamomilla, cina, helianthemum nummularium, flos, ignatia amara, kali bromatum, lycopodium clavatum, mimulus guttatus, flos, paeonia officinalis, phosphorus, populus tremula, flos, phus toxicodendron, stramonium, sulphur, viola odorata liquid

  • 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 13, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________

    HPUS active ingredients Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Rhus toxicodendron, Stramonium, Sulphur, Viola odorata.  ​Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses a natural aid for: frightening dreams, night terrors, restless tossing.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water base, citric acid, potassium sorbate.

  • WARNINGS

    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.

  • 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.
    • Adults: 3 sprays 3 times per day.
    • Children 2-12 years: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Uses a natural aid for: frightening dreams, night terrors, restless tossing.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FEARS AND NIGHTMARES 
    aconitum napellus, aesculus carnea, flos, allium sativum, aurum bromatum, calcarea carbonica, chamomilla, cina, helianthemum nummularium, flos, ignatia amara, kali bromatum, lycopodium clavatum, mimulus guttatus, flos, paeonia officinalis, phosphorus, populus tremula, flos, phus toxicodendron, stramonium, sulphur, viola odorata liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-1810
    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
    AESCULUS CARNEA FLOWER (UNII: 717DPT98VM) (AESCULUS CARNEA FLOWER - UNII:717DPT98VM) AESCULUS CARNEA FLOWER10 [hp_X]  in 59 mL
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC10 [hp_X]  in 59 mL
    GOLD TRIBROMIDE (UNII: 4PJV3VH75Y) (GOLD TRIBROMIDE - UNII:4PJV3VH75Y) GOLD TRIBROMIDE10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP10 [hp_X]  in 59 mL
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    MIMULUS GUTTATUS FLOWERING TOP (UNII: 192426I5JU) (MIMULUS GUTTATUS FLOWERING TOP - UNII:192426I5JU) MIMULUS GUTTATUS FLOWERING TOP10 [hp_X]  in 59 mL
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    POPULUS TREMULA FLOWERING TOP (UNII: 5Q01F7TPJJ) (POPULUS TREMULA FLOWERING TOP - UNII:5Q01F7TPJJ) POPULUS TREMULA FLOWERING TOP10 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-1810-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/08/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-1810)