Label: FIBROCANE CALM- aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, passiflora incarnata, pulsatilla, valeriana officinalis 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 June 24, 2014

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  • INDICATIONS & USAGE

    Indications: FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, worry or inability to fall or stay asleep.

  • ACTIVE INGREDIENT

    Active Ingredients: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient at 10X, 30X, LM1 potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric acid, potassium sorbate, purified water.

  • DOSAGE & ADMINISTRATION

    Directions: Initially, depress pump until primed. Hold close and spray directly into your mouth. Take 2 pump sprays twice daily, morning and evening. Additional sprays may be taken during the night as needed. For ages 12 and above.

  • WARNINGS

    Warnings

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

    • Keep out of reach of children.
  • OTHER SAFETY INFORMATION

    Other Information:

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

  • PURPOSE

    FibroCane Calm temporarily relieves symptoms due to occasional sleeplessness:

    • restlessness
    • nervousness
    • exhaustion
    • excitability
    • worry or inability to fall or stay asleep
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FIBROCANE CALM 
    aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, passiflora incarnata, pulsatilla, valeriana officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57850-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 29.6 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 29.6 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 29.6 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 29.6 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 29.6 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 [hp_X]  in 29.6 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 29.6 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 29.6 mL
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT10 [hp_X]  in 29.6 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 29.6 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 29.6 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 29.6 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 29.6 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57850-0001-129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/31/2013
    Labeler - Premier Bioceuticals LLC. (027714978)
    Registrant - Premier Bioceuticals LLC. (027714978)
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