Label: SPRAYOLOGY STRESS RELIEF- agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, 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 February 26, 2014

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

  • ACTIVE INGREDIENT

    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

  • WARNINGS

    Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children over 12: 2 sprays into the mouth each 60 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
    • Ages 2 to 12: 1 spray into the mouth each 60 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.
    • Under age 2: consult a health care professional.
  • PURPOSE

    Temporarily relieves feelings of stress, including:

    • anxiety
    • nervousness
    • mood swings
    • irritability
  • OTHER SAFETY INFORMATION

    Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

  • INDICATIONS & USAGE

    Temporarily relieves feelings of stress, including:

    ° anxiety

    ° nervousness

    ° mood swings

    ° irritability

    ° natural

    ° gluten free

    ° no artificial flavors or colors

    ° no known negative side effects

    ° no known negative drug interactions

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPRAYOLOGY STRESS RELIEF 
    agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-0006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE6 [hp_X]  in 41 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 41 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK6 [hp_X]  in 41 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 41 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER200 [hp_C]  in 41 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [hp_C]  in 41 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 41 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 41 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61096-0006-11 in 1 CARTON
    141 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/26/2014
    Labeler - Eight and Company (927364120)
    Registrant - Eight and Company (927364120)