Label: PASSIFLORA INCARNATA 1X- passiflora incarnata liquid

  • 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 29, 2015

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Passiflora incarnata 1X HPUS

  • Inactive Ingredients

    Ethyl alcohol, Water

  • Purpose

    Sleep disorders

  • Uses

    Sleep disorders

  • Warnings

    If pregnant or breast feeding ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Direction

    Adult or child: Five drops in 3 tea spoons of water, leaving a gap of 30 minutes from any food or as advised by your physician.

  • Manufactured by

    Paramesh Banerji Life Sciences, LLC

    220 North Center Drive

    North Brunswick, NJ 08902, USA

    Product of USA

    Tel: +1-732-743-5936

  • Principal Display Panel

    Passiflora incarnata 1X

    Homeopathic Product

    Passiflora incarnata 1X

    Homeopathic Product

    Passiflora incarnata 1X HPUS

    Sleep disorders

    Quantity

    8mL

  • INGREDIENTS AND APPEARANCE
    PASSIFLORA INCARNATA 1X 
    passiflora incarnata liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69152-1569
    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 TOP1 [hp_X]  in 8 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (Greenish Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69152-1569-18 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2015
    Labeler - Paramesh Banerji Life Sciences LLC (079393726)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paramesh Banerji Life Sciences LLC079393726manufacture(69152-1569) , pack(69152-1569) , label(69152-1569)