Label: PASSIFLORA INCARNATA KIT REFILL- passiflora incarnata flowering top pellet

  • NDC Code(s): 71919-775-01
  • 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 July 13, 2022

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  • ACTIVE INGREDIENTS

    PASSIFLORA

  • USES

    To relieve the symptoms of insomnia.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    PASSIFLORA   Insomnia

  • STOP USE AND ASK DOCTOR

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

  • DIRECTIONS

    Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    The OTC potency range of PASSIFLORA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

    Availability is subject to change.

    Label

    All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

    ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

    Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

  • INGREDIENTS AND APPEARANCE
    PASSIFLORA INCARNATA KIT REFILL 
    passiflora incarnata flowering top pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71919-775
    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 TOP200 [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:71919-775-01350 in 1 VIAL, GLASS; Type 0: Not a Combination Product07/13/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/13/2022
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(71919-775)
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