Passiflora Plex

Manufacturer
Seroyal USA | SAN'UP
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:14:41

Label at a glance#

ProductPassiflora Plex
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, IPOMOEA PURGA ROOT, ARABICA COFFEE BEAN, MAGNESIUM, PALLADIUM, TELLURIUM, PHOSPHORIC ACID, STRYCHNOS IGNATII SEED
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Uses

For the temporary relief of symptoms associated with

irregular sleep patterns
ordinary restlessness

WARNINGS SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol,

purified water.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-1322-062106-1322-0

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)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1322-0Passiflora Plex1 in 1 BOXLIQUID15
62106-1322-0Passiflora Plex30 mL in 1 BOTTLE, GLASSLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1322PASSIFLORA PLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUM) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20210716_0eabdf34-4d4c-3282-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
IPOMOEA PURGA ROOTACTIVE INGREDIENT4UDO46YBK21
MAGNESIUMACTIVE INGREDIENTI38ZP9992A1
PALLADIUMACTIVE INGREDIENT5TWQ1V240M1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
TELLURIUMACTIVE INGREDIENTNQA0O090ZJ1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
IPOMOEA PURGA ROOTACTIVE MOIETY4UDO46YBK21
MAGNESIUMACTIVE MOIETYI38ZP9992A1
PALLADIUMACTIVE MOIETY5TWQ1V240M1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
TELLURIUMACTIVE MOIETYNQA0O090ZJ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-132262106-1322-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii+route
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii+route
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii+route
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii+route
12 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Passiflora PlexPASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUMSeroyal USA0eabdf34-4d4c-3282-e054-00144ff8d46c2021-07-15WarningsExact identifier
ndc (package): 62106-1322-0
ndc (product): 62106-1322
ndc11 (package): 62106132200
spl id: c72da14a-dfce-c8a3-e053-2995a90a7983
spl set id: 0eabdf34-4d4c-3282-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.