FDA Label for Passiflora Plex
View Indications, Usage & Precautions
Passiflora Plex Product Label
The following document was submitted to the FDA by the labeler of this product Seroyal Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - 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.
Package Label.Principal Display Panel
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)
* Please review the disclaimer below.