The following Structured Product Label (SPL) was submitted to the FDA by San�up for the product Passiflora Plex (NDC 52503-1322). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Uses
For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.
Uses
For the temporary relief of symptoms associated with irregular sleep patterns and 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.
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.
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 ingredients
Ethanol (beet), purified water
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)
* Please review the disclaimer below.
