Label: SPRAYOLOGY STRESS RELIEF- agnus, avena, cinchona, humulus, hyoscyamus, ignatia, passiflora, valeriana liquid

  • NDC Code(s): 61096-2006-1
  • Packager: Eight and Company L.L.C
  • 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 16, 2023

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  • ACTIVE INGREDIENTS:

    Agnus 6X, Avena 4X, Cinchona 6X, Humulus 4X, Hyoscyamus 200C, Ignatia 200C, Passiflora 4X, Valeriana 4X

  • PURPOSE:

    Temporarily relieves feelings of stress, including:

    • anxiety
    • nervousness
    • mood swings
    • irritability
  • 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. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • 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.

    Under age 12: consult a health care professional.

  • OTHER INFORMATION:

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

  • INDICATIONS:

    Temporarily relieves feelings of stress, including:

    ° anxiety

    ° nervousness

    ° mood swings

    ° irritability

    ° natural

    ° gluten & lactose free

    ° no artificial flavors or colors

    ° no known negative side effects

    ° no known negative drug interactions

  • INACTIVE INGREDIENTS:

    Non-GMO glycerin, v/v, organic alcohol 20% v/v and purified water.

  • QUESTIONS:

    Mfd. for Eight and Company L.L.C.

    Gaithersburg, MD 20879 1.800.377.5787

    www.sprayology.com

  • PACKAGE LABEL DISPLAY:

    NDC 61096-2006-1

    sprayology

    Stress Relief

    RESTORES CALM

    HOMEOPATHIC ORAL SPRAY

    1.38 fl.oz (41 ml)

    Stress Relief LBL

    Stress Relief CNT

  • INGREDIENTS AND APPEARANCE
    SPRAYOLOGY STRESS RELIEF 
    agnus, avena, cinchona, humulus, hyoscyamus, ignatia, passiflora, valeriana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-2006
    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 TOP4 [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) HOPS4 [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 TOP4 [hp_X]  in 41 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [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:61096-2006-11 in 1 CARTON03/25/2019
    141 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/25/2019
    Labeler - Eight and Company L.L.C (927364120)
    Registrant - Apotheca Company (844330915)
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