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 May 10, 2018

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.

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  • 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

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  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • Uses

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

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  • PURPOSE

    Insomnia Relief

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  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1120
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X]
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS 6 [hp_X]
    SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA 6 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 6 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 12 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 12 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code leafman
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62795-1120-4 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/31/2016
    Labeler - MediNatura Inc (079324099)
    Establishment
    Name Address ID/FEI Business Operations
    MediNatura Inc 102783016 manufacture(62795-1120)
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