Label: PASSIFLORA INCARNATA- passion flower granule

  • 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 24, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredients

    PASSIFLORA INCARNATA 30K GR

    PASSIFLORA INCARNATA 4CH GR

    PASSIFLORA INCARNATA 6CH GR

  • PURPOSE

    Indications

    For the temporary relief of sleeplessness and restlessness

  • WARNINGS

    Warning:
    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    For the temporary relief of sleeplessness and restlessness

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-8562

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-8562-4
    PASSIFLORA INCARNATA
    Passion flower
    140 granules
    Indications

    For the temporary relief of sleeplessness and restlessness

  • INGREDIENTS AND APPEARANCE
    PASSIFLORA INCARNATA 
    passion flower granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-8562
    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]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-8562-410 in 1 CARTON05/28/2015
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/28/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-8562)