Label: GUNA SLEEP SUPPORT- avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ drops

  • 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 January 17, 2021

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  • Uses:

    • Helps to relax and fall asleep,
    • Helps to stay asleep during the night
  • INDICATIONS & USAGE

    Take 15 minutes before meals.

  • INACTIVE INGREDIENT

    inactive ingredient: Ethyl alcohol 30%.

  • QUESTIONS

    Questions?: info@gunainc.com

    Tel. (484) 223-3500


  • DOSAGE & ADMINISTRATION



    Adults and children 12 years and older: 20 drops in a little water, 2 times per day



    Children between 12 and 6 years of age: 10 drops in a little water, 2 times per day



    Children under 6 years: consulta a physician

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

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

  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days.
    • If pregnant or breast-feeding ask a health care professional before use.
    • Keep out of reach of children. In case of overdose, get professional assistance or contact a Poison Control Center immediately.
    • Contains ethyl alcohol 30%






  • active ingredient/purpose

    Avena sativa 2X Helps relaxation, helps sleep

    Chamomilla 2X Helps relaxation, helps sleep

    Caffeinum 6X Helps relaxation

    Ignatia amara 4X Relieves nervousness

    Kali bromatum 4X Helps sleep

    Passiflora incarnata 2X Supports nighttime sleep

    Zincum valerianicum 4X Supports nighttime sleep

  • PRINCIPAL DISPLAY PANEL

    5USSLS-4

  • INGREDIENTS AND APPEARANCE
    GUNA SLEEP SUPPORT 
    avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-471
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE4 [hp_X]  in 30 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE6 [hp_X]  in 30 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 30 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE2 [hp_X]  in 30 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED4 [hp_X]  in 30 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]  in 30 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE30 [hp_X]  in 30 mL
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-471-181 in 1 BOX01/17/2021
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/17/2021
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-471)
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