Label: BIO RES Q- clematis vitalba flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, prunus cerasifera, flos liquid

  • NDC Code(s): 43857-0108-1
  • Packager: BioActive Nutritional, 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 July 25, 2017

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  • ACTIVE INGREDIENTS:

    Clematis Vitalba, Flos 6X, 30C, 200C, Helianthemum Nummularium, Flos 6X, 30C, 200C, Impatiens Glandulifera, Flos 6X, 30C, 200C, Ornithogalum Umbellatum, Flos 6X, 30C, 200C, Prunus Cerasifera, Flos 6X, 30C, 200C.

  • INDICATIONS:

    For temporary relief of trauma, numbness, terror, panic, irritability, tension and fear.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of trauma, numbness, terror, panic, irritability, tension and fear.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    BIO RES Q

    6X, 30C, 200C

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Bio Res Q 6X, 30C, 200C

  • INGREDIENTS AND APPEARANCE
    BIO RES Q 
    clematis vitalba flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, prunus cerasifera, flos liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER6 [hp_X]  in 1 mL
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER6 [hp_X]  in 1 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER6 [hp_X]  in 1 mL
    ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP6 [hp_X]  in 1 mL
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0108-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/03/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0108) , api manufacture(43857-0108) , label(43857-0108) , pack(43857-0108)
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