Label: COMBINATION REMEDY 20 - INSOMNIA- coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis 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 25, 2017

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  • WARNINGS

    Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

    If pregnant or breast-feeding, ask health professional before use.

    Do not use if tamper evident seal is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    Coffea Cruda 1X

    Hyoscyamus Niger 1X

    Ignatia Amara 1X

    Passiflora Incarnata 1X

    Valeriana Officinalis 1x

  • PURPOSE

    Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

  • INACTIVE INGREDIENT

    Purified Water

    Alcohol

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

    Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

    Children under 2 years: Consult doctor prior to use.

  • INDICATIONS & USAGE

    Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

  • PRINCIPAL DISPLAY PANEL

    insomnia combo 20 rev.jpg

  • INGREDIENTS AND APPEARANCE
    COMBINATION REMEDY 20 - INSOMNIA 
    coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED1 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN1 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER1 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69008-4070-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/15/2017
    Labeler - Warsan Homoeopathic Laboratories (645579772)
    Registrant - Warsan Homoeopathic Laboratories (645579772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Warsan Homoeopathic Laboratories645579772manufacture(69008-4070) , pack(69008-4070) , label(69008-4070)
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