PASSIFLORA PLEX- passiflora incarnata, ignatia amara, jalapa, coffea cruda, magnesium metalicum, palladium metallicum, tellurium metallicum, phosphoricum acidum liquid 
Seroyal USA

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.

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Passiflora Plex

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

Uses

For the temporary relief of symptoms associated with

irregular sleep patterns
ordinary restlessness

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.

If pregnant or breast feeding, 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.

Inactive ingredients

Ethanol,

purified water.

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.

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 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.

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)

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)

Revised: 7/2021
Document Id: c72da14a-dfce-c8a3-e053-2995a90a7983
Set id: 0eabdf34-4d4c-3282-e054-00144ff8d46c
Version: 5
Effective Time: 20210715
 
Seroyal USA