Label: GUNA-SLEEP- avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian - 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 December 21, 2018

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  • ACTIVE INGREDIENT

    Avena sativa 6C Nervousness

    Chamomilla 6C Restlessness

    Helleborus niger 6C Mental stress

    Ignatia amara 6C Restlessness

    Interleukin 1 beta 4C Immune support

    Melatonin 4C Hormonal regulation

    Melissa officinalis 6C Anxiety

    Pineal gland 6X 12X 30X Hormonal regulation

    Pulsatilla 6C Mood support

    Serotonin 6C Hormonal support

    Valeriana officinalis 6C Restlessness

  • PURPOSE

    Temporary relief of:

    • Difficulty falling asleep
  • WARNINGS

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




  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a doctor before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION


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

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

    Children under 6 years 5 drops in a glass of water, , 2 times per day

  • QUESTIONS

    Questions?: info@gunainc.com
    Tel. (484) 223-3500

  • INACTIVE INGREDIENT

    inactive ingredient: Ethyl alcohol 30%.

  • INDICATIONS & USAGE

    Take 15 minutes before meals.

  • PRINCIPAL DISPLAY PANEL

    5USSLE-Rev02-04-07-18

  • INGREDIENTS AND APPEARANCE
    GUNA-SLEEP 
    avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-294
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_C]  in 30 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_C]  in 30 mL
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT6 [hp_C]  in 30 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_C]  in 30 mL
    CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93) CANAKINUMAB4 [hp_C]  in 30 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN4 [hp_C]  in 30 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS6 [hp_C]  in 30 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND12 [hp_X]  in 30 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]  in 30 mL
    SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN6 [hp_C]  in 30 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-294-181 in 1 BOX12/21/2018
    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 homeopathic05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-294)
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