PASSIFLORA PLEX

Manufacturer
San’Up
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:44:51

Label at a glance#

ProductPASSIFLORA PLEX
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, ARABICA COFFEE BEAN, MAGNESIUM, STRYCHNOS IGNATII SEED, IPOMOEA PURGA ROOT, PALLADIUM, TELLURIUM, PHOSPHORIC ACID
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Each drop contains:

Coffea cruda (Coffee) Unroasted 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 - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Uses

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

INDICATIONS & USAGE SECTION


Uses

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

Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.

Directions

To be taken 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner.

Children (under 12 years) .Take under the direction of your healthcare practitioner.

DOSAGE & ADMINISTRATION SECTION

Directions

To be taken 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner.

Children (under 12 years) .Take under the direction of your healthcare practitioner.

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.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol (beet), purified water

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or worsen.

OVERDOSAGE SECTION

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

OTHER SAFETY 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.

Indications & Usage section

RECENT MAJOR CHANGES SECTION

Addition of:

"Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration."

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Passiflora plex.jpgPassiflora plex.jpg

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

30 mL (1 fl oz)

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ARABICA COFFEE BEAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52503-1322-0PASSIFLORA PLEX1 in 1 CARTONLIQUID14
52503-1322-0PASSIFLORA PLEX30 mL in 1 BOTTLE, GLASSLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52503-1322PASSIFLORA PLEX (PASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUM) LIQUID [SAN’UP]4Current NDC, Legacy NDC, 2 package rows20211111_937b6700-3ba8-0266-e053-2995a90a3318.zip

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
52503-132252503-1322-0

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

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 ACIDUMSanUp937b6700-3ba8-0266-e053-2995a90a33182021-11-10WarningsExact identifier
ndc (package): 52503-1322-0
ndc (product): 52503-1322
ndc11 (package): 52503132200
spl id: d06cb8b2-b26e-95ad-e053-2995a90aa3b0
spl set id: 937b6700-3ba8-0266-e053-2995a90a3318

Reported adverse events (FAERS/openFDA)#

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