Label: HENDEL INSOMNIA RELIEF- passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tablet

  • 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 October 14, 2019

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

  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use if sensitivity to Insomnia Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

  • ACTIVE INGREDIENT

    Each tablet contains equal parts of Passiflora incarnata 2X; Amber grisea 6X; Scutellaria lateriflora 6X; Zincum valerianicum 6X; Cocculus indicus 12X; Coffea cruda 12X

  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

  • Directions

    Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before going to bed or as directed
    by a physician.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    For the temporary relief of:
    • Occasional Nervous Restlessness
    • Occasional Sleeplessness
    • Frequent Awakening

  • PURPOSE

    Insomnia Relief

  • PRINCIPAL DISPLAY PANEL

    Hendel Insomnia Relief.jpg

  • INGREDIENTS AND APPEARANCE
    HENDEL INSOMNIA RELIEF 
    passiflora incarnata flowering top, ambergris, scutellaria lateriflora, zinc valerate dihydrate, anamirta cocculus seed, and arabica coffee bean tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS6 [hp_X]
    SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA6 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE6 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED12 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1120-4100 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/31/2016
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1120)