Label: HENDEL HOMEOPATHIC CALM- avena sativa flowering top, matricaria chamomilla, hops, passiflora incarnata flowering top, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur 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 August 22, 2022

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  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Homeopathic Calm or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS

    Restlessness Occasional and simple nervous tension

  • ACTIVE INGREDIENTS

    Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X

  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

  • DOSAGE

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

  • USES

    For the temporary relief of:
    • Restlessness
    • Occasional simple nervous tension

  • PRINCIPAL DISPLAY PANEL

    Hendel Homeopathic Calm

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  • INGREDIENTS AND APPEARANCE
    HENDEL HOMEOPATHIC CALM 
    avena sativa flowering top, matricaria chamomilla, hops, passiflora incarnata flowering top, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1118
    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 TOP2 [hp_X]
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA2 [hp_X]
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE6 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [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:62795-1118-2100 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package08/01/201609/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/201609/30/2026
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1118)
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