Label: ANXIETY- agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis spray

  • 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 1, 2015

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

  • ACTIVE INGREDIENTS:

    Agnus Castus 6X, Avena Sativa 1X, Cinchona Officinalis 6X, Humulus Lupulus 2X, Hyoscyamus Niger 200C, Ignatia Amara 200C, Passiflora Incarnata 3X, Valeriana Officinalis 3X.

  • INDICATIONS:

    Calming homeopathic oral spray for the temporary relief of nervousness & sleeplessness associated with anxiety & tension.†

    †These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    If symptoms persist, consult a doctor.

    If pregnant or breast feeding, ask a doctor before use.

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

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

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults & children over 12. Spray twice under the tongue 3 times per day. For acute symptoms, dosage may be administered up to six times per day. Children 12 & under. Consult a doctor prior to use.

  • INDICATIONS:

    Calming homeopathic oral spray for the temporary relief of nervousness & sleeplessness associated with anxiety & tension.†

    †These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Organic alcohol 20% v/v, purified water.

  • QUESTIONS:

    Distributed by: BIOVEA

    Dallas, TX 75202

    1-800-961-4750

    www.biovea.com

  • PACKAGE LABEL DISPLAY:

    NDC# 69607-0006-1

    BIOVEA

    HOMEOPATHICS

    Anxiety

    Homeopathic

    1 FL. OZ. (30ml)

    STRESS & SLEEP†

    Anxiety

  • INGREDIENTS AND APPEARANCE
    ANXIETY 
    agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69607-0006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE6 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK6 [hp_X]  in 1 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER200 [hp_C]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [hp_C]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69607-0006-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2015
    Labeler - Biovea (089173699)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(69607-0006) , api manufacture(69607-0006) , label(69607-0006) , pack(69607-0006)