Label: PASSIFLORA PLEX- passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum 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 July 15, 2021

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  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Coffea cruda (Coffee) Seed 10X
    Ignatia amara (St. Ignatius’ bean) Seed 8X
    Jalapa (Jalap) Tuber 8X
    Magnesium metallicum (Magnesium) 10X
    Passiflora incarnata (Passion flower) Aerial Parts 3X
    Phosphoricum acidum (Phosphoric acid) 14X
    Palladium metallicum (Palladium) 10X
    Tellurium metallicum (Tellurium) 10X

  • PURPOSE

    Uses

    For the temporary relief of symptoms associated with

    irregular sleep patterns
    ordinary restlessness

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    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 breast feeding, 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

    Ethanol,

    purified water.

  • DOSAGE & ADMINISTRATION

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of symptoms associated with

    irregular sleep patterns
    ordinary restlessness

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • PRINCIPAL DISPLAY PANEL

    62106-1322-0

    NDC 62106-1322-0

    UNDA

    plex

    PASSIFLORA PLEX

    Homeopathic Preparation

    For the temporary relief of symptoms
    associated with irregular sleep patterns
    and ordinary restlessness.

    Contains 60% Alcohol
    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    PASSIFLORA PLEX 
    passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1322
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 30 mL
    IPOMOEA PURGA ROOT (UNII: 4UDO46YBK2) (IPOMOEA PURGA ROOT - UNII:4UDO46YBK2) IPOMOEA PURGA ROOT8 [hp_X]  in 30 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 30 mL
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM10 [hp_X]  in 30 mL
    PALLADIUM (UNII: 5TWQ1V240M) (PALLADIUM - UNII:5TWQ1V240M) PALLADIUM10 [hp_X]  in 30 mL
    TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ) TELLURIUM10 [hp_X]  in 30 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID14 [hp_X]  in 30 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED8 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1322-01 in 1 BOX02/09/2015
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/09/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1322)
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