Label: INSOMNIA- matricaria recutita - arabica coffee bean - hyoscyamus niger - strychnos ignatii seed - passiflora incarnata top pellet

  • NDC Code(s): 68428-021-14
  • Packager: Washington Homeopathic Products
  • 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 23, 2019

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  • ACTIVE INGREDIENTS

    CHAMOMILLA    6C

    COFFEA CRUDA    6C

    HYOSCYAMUS   6C

    IGNATIA       6C

    PASSIFLORA  6C

  • USES

    To relieve the symptoms of caused by grief, intense mental application, stress. Non-habit forming. Will not cause drowsiness.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    CHAMOMILLA    Irritability

    COFFEA CRUDA    Sleeplessness

    HYOSCYAMUS   Twitching

    IGNATIA       Sadness

    PASSIFLORA  Insomnia

  • STOP USE AND ASK DOCTOR

    If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

  • DIRECTIONS

    Adults 2 pellets every 3 hours for 2 days. Then 2 pellets morning and night for 2 weeks.

    Children: 1 pellet. Repeat as necessary.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    image of bottle labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    INSOMNIA 
    matricaria recutita - arabica coffee bean - hyoscyamus niger - strychnos ignatii seed - passiflora incarnata top pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_C]
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [hp_C]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_C]
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68428-021-14300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2010
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-021)
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