Label: FEARS AND NIGHTMARES- aconitum napellus, aurum bromatum, calcarea carbonica, chamomilla, cina, ignatia amara, kali bromatum, lycopodium clavatum, paeonia officinalis, phosphorus, stramonium, sulphur 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 April 1, 2014

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

  • ACTIVE INGREDIENT

    HPUS active ingredients: ​Aconitum napellus, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Ignatia amara, Kali bromatum, Lycopodium clavatum, Paeonia officinalis, Phosphorus, Stramonium, Sulphur. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

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  • PURPOSE

    Uses​ a natural aid for: frightening dreams, night terrors, crying, talking or screaming in sleep, restless tossing, anxiety, jerking, twitching, waking up terrified, general fears day or night, phobias.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water base, Citric acid and Potassium sorbate.

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  • WARNINGS

    Warning

    • Stop use and ask a doctor. If symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
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  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
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  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Ages 12 and up 3 sprays 3 times per day.
    • Ages 2-12 2 sprays 3 times per day.
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  • OTHER SAFETY INFORMATION

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

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  • INDICATIONS & USAGE

    Uses ​a natural aid for:

    • frightening dreams
    • night terrors
    • crying, talking or screaming in sleep
    • restless tossing
    • anxiety, jerking, twitching, waking up terrified
    • general fears day or night
    • phobias
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  • INGREDIENTS AND APPEARANCE
    FEARS AND NIGHTMARES 
    aconitum napellus, aurum bromatum, calcarea carbonica, chamomilla, cina, ignatia amara, kali bromatum, lycopodium clavatum, paeonia officinalis, phosphorus, stramonium, sulphur liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5099
    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
    GOLD TRIBROMIDE (UNII: 4PJV3VH75Y) (GOLD TRIBROMIDE - UNII:4PJV3VH75Y) GOLD TRIBROMIDE 10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X]  in 59 mL
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 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
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 10 [hp_X]  in 59 mL
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT 10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X]  in 59 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57955-5099-2 59 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/01/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio Inc. 617901350 manufacture(57955-5099)
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